Hepatitis B Clinical Trials

The future is bright for people with chronic hepatitis B, thanks in a large part to advancements in medical science. All drugs must go through a testing process, which involves three phases of clinical trials, to evaluate its safety and effectiveness before being approved.

Volunteering for a clinical trial program can be very valuable. Expensive blood work, treatment medications, and doctor's visits are usually provided free of charge for those accepted into a study. Clinical trials also provide the opportunity to potentially benefit from the latest advances in medical science.

The Hepatitis B Foundation regularly updates this page to provide the most current hepatitis B clinical trial sites in the United States and abroad. Please contact us if you have any questions about clinical trials or know of a drug trial that is not listed.

Click the following links for:

International HBV Clinical Trials, Co-Infection Clinical Trials, Pediatric Clinical Trials, HBV & Liver Transplantation Clinical Trials, HBV & Liver Cancer and HBV Reactivation and Lymphoma

Updated May 2, 2012

U.S. CLINICAL TRIALS

*CHB=Chronic hepatitis B

Withdrawal of Therapy After Long-Term Antiviral Treatment for CHB – U.S. only
Withdraw therapy and follow HBeAg pos and neg CHB patients to determine the best time to stop treatment and prevent the disease from causing further liver damage. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. Marc Ghany at 301-402-5115 marcg@mail.nih.gov. Refer to identifier - NCT01581554 (Study ID#110151, 11-DK-0151)

Entecavir and Peginterferon for Immune Tolerant Adults With CHB – U.S. only
Determine whether entecavir and peginterferon can be used to treat people in the immune-tolerant phase of chronic hepatitis B. Contact: Nancy Fryzek at 301-435-6122 nancy.fryzek@nih.gov or Dr. Marc Ghany at 301-402-5115 marcg@mail.nih.gov. Refer to identifier - NCT01534611

Observational Study of Persons With Hepatitis B Virus Infection in North America – North America only
Long-term study of those with chronic HBV to improve current knowledge on the disease and long-term disease progression. Contact: Elenita Rivera, RN at 301-496-3531 erivera@cc.nih.gov or Dr. Marc Ghany at 301-402-5115 marcg@mail.nih.gov and refer to identifier - NCT01306071 (Study ID # 110108, 11-DK-0108)

Long-term Study of Liver Disease in Patients with HBV and/or HCV with or w/out HIV – U.S. only
Study to understand how these viruses affect the immune system over the long-term. Annual visit with researcher, but patient must have a primary care doctor. Contact: Colleen Kotb, RN 202-857-7652 kotbch@mail.nih.gov or Dr. Shyamasundaran Kottilil 301-435-0936 skottilil@niaid.nih.gov Refer to identifier - NCT01350648 (Study ID # 110152, 11-CC-0152)

Simvastatin for the Treatment of CHB – U.S. only
Phase 1, safety/efficacy, 3-arm study: simvastatin monotherapy, simvastatin plus tenofovir and simvastatin plus entecavir for treatment naïve CHB. Contact: Paula Allen at Paula.Allen@va.gov , 405-456-3982, or Joe Cardello at Joe-Cardello@va.gov , 405-456-3982. Refer to identifier NCT00994773 (Study ID # HBV 106707)

Evaluation of Patients With Liver Disease – U.S. only
Evaluate, investigate and follow-up patients suffering from acute and chronic liver disease. Qualified patients may be able to participate in other offered studies. Contact: Hwa Lih Han at 301-496-1665 hanhl@niddk.nih.gov or Dr. T. Jake Liang at 301-496-1721 jakel@bdg10.niddk.nih.gov . Refer to identifier - NCT00001971 (Study ID # 910214, 91-DK-0214)

Long-term Study on Anti-HBV Effect of Tenofovir (TDF) and Resistance Surveillance in Asian American Adult Patients – U.S. only
Phase IV observational study evaluating antiviral efficacy, safety, tolerability, virological response & mutations based on TDF in HBV infected Asian-Americans. Contact: Dr. C. Pan at cpan11355@yahoo.com or call 718-888-7728 and refer to identifier- NCT01267162 (Study ID # IN-US-174-0156)

Tenofovir Alone vs. Tenofovir with Emtricitabine for CHB – U.S. Only
Test whether the combination of two medications, tenofovir and emtricitabine are safer and more effective for treating CHB than tenofovir alone. Contact: Elenita Rivera, RN at 301-496-3531 erivera@cc.nih.gov or Dr. Marc Ghany at 301-402-5115 marcg@mail.nih.gov.and refer to identifier - NCT00524173 (Study ID# 070207, 07-DK-0207)

HBV Viral Suppression by Entecavir in Adefovir Partial Responders (ADVPR) – U.S. Only
Study for patients who have not been treated with 48 weeks of Entecavir (ENT) following partial response to adefovir (ADV). Contact: Nghia Nguyen at (408) 995-0333 nghianguyen214@gmail.com, or Long Nguyen at (408) 995-0333 longnguyen07@gmail.com and refer to identifier - NCT00704106 (Study ID# PHF008)

Tenofovir (TDF) in Combination with PEG vs. TDF Monotherapy or PEG Monotherapy for 48 Weeks in CHB Patients – U.S. and Canada
Evaluate safety and efficacy of TDF plus PEG combo therapy vs. TDF monotherapy or PEG monotherapy in non-cirrhotic CHB patients as determined by loss of HBsAg. Contact: Eduardo Martins at +1 650-522-5792 - Eduardo.Martins@gilead.com or Prista Charuworn +1 650-372-7961 –Prista.Charuworn@gilead.com and refer to identifier - NCT01277601 (Study ID # GS-US-174-0149)

Hepatitis B Research Network Adult Cohort Study (HBRN) – U.S. and Canada
A study to identify factors that cause HBV disease to activate or worsen. Contact: Jennifer Dobberstein 412-624-5555 or dobbersteinj@edc.pitt.edu and refer to identifier -NCT01263587 (Study ID # DK082864, U01DK082864)

HBRN: Immune Regulation and Costimulation in Natural History of CHB – U.S. and Canada
Ancillary to NIDDK-sponsored HBRN cohort study that will examine the balance between immune regulatory and effector response in CHB participants enrolled in the HBRN study (NCT01263587). Contact: Mary Valiga, RN 215-823-5800 ext. 6726 or mevaliga@mail.med.upenn.edu and refer to identifier NCT01298037 Study ID # DK082864 HBRN Immunology, U01DK082864

Dose Ranging Study of pegIFN lambda in HBeAg (+) CHB Patients –U.S. and International
Identify dose of pegIFN that is safe, well tolerated and efficacious for CHB treatment. Contact: For trials within U.S., refer to site phone no. listed. For site info outside U.S. contact BMS at Clinical.Trials@bms.com and refer to identifier-NCT01204762 (Study ID # Al452-005, 2010-020387-38) First line of email MUST contain NCT# & site#.

Pegasys Monotherapy in Patients with CHB Who Have Participated in Previous Studies – U.S. and International
An open-label multicenter study with Pegasys monotherapy in eligible patients who will have completed treatment on another donor protocol. Contact: 888-662-6728 or genentechclinicaltrials@druginfo.com and refer to study ID # PP22612. (identifier - NCT00962975 )

Early Immunologic Response in Asian Patients with CHB treated with Pegasys, Nucloside Analogues or Both – U.S. and International
An open-label, randomized, parallel-arm study which will assess the early immunologic response in treatment-naive Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Contact: Hoffmann-La Roche at 888-662-6728 (U.S. only) or genentechclinicaltrials@druginfo.com and refer to Study ID # PP22512, identifier - NCT00962871

INTERNATIONAL CLINICAL TRIALS

*CHB=Chronic hepatitis B

Hepatitis B Research Network Adult Cohort Study (HBRN) – U.S. and Canada
A study to identify factors that cause HBV disease to activate or worsen. Contact Jennifer Dobberstein 412-624-5555 or dobbersteinj@edc.pitt.edu and refer to identifier -NCT01263587 (Study ID # DK082864, U01DK082864)

HBRN: Immune Regulation and Costimulation in Natural History of CHB – U.S. and Canada
Ancillary to NIDDK-sponsored HBRN cohort study that will examine the balance between immune regulatory and effector response in CHB participants enrolled in the HBRN study (NCT01263587). Contact: Mary Valiga, RN 215-823-5800 ext. 6726 or mevaliga@mail.med.upenn.edu and refer to identifier - NCT01298037 (Study ID # DK082864 HBRN Immunology, U01DK082864)

Dose Ranging Study of pegIFN lambda in HBeAg (+) CHB Patients – U.S. and International
Identify dose of pegIFN that is safe, well tolerated and efficacious for CHB treatment. Contact: For trials within U.S., refer to site phone no. listed. For site info outside U.S. contact BMS at Clinical.Trials@bms.com. First line of email MUST contain NCT# & Site# Refer to identifier - NCT01204762 (Study ID # Al452-005, 2010-020387-38)

Pegasys Monotherapy in Patients with CHB Who Have Participated in Previous Studies –U.S. and International
An open-label multicenter study with Pegasys monotherapy in eligible patients who will have completed treatment on another donor protocol Contact Hoffman-La Roche: 888-662-6728 or genentechclinicaltrials@druginfo.com and refer to Study ID # PP22612, identifier - NCT00962975.

Early Immunologic Response in Asian Patients with CHB treated with Pegasys, Nucleoside Analogues or both – U.S. and International
An open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naive Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Contact: Hoffmann-La Roche at 888-662-6728 (US only) or genetechclinicaltrials@druginfo.com and refer to Study ID # PP22512, identifier - NCT00962871.

Telbivudine or Tenofovir Treatment in HBeAg (-) CHB Patients based on Roadmap Concept (LDT600A) – International only
Evaluate efficacy and safety following Roadmap Concept – initial monotherapy with Telbivudine or tenofovir in HBeAg (-) CHB patients. Contact: Novartis Pharmaceuticals at +41-61-324-1111 and refer to identifier NCT01379508 (Study ID # CLDT600A2409)

Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of Pegasys in Patients With HBeAg (+) CHB – International only
A long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg (+) CHB. Patients who received treatment with PEGASYS, and completed follow-up are eligible to enter this post-treatment follow-up study. Contact: Hoffman-La Roche 888-662-6728 (U.S. only) or genentechclinicalstrials@druginfo.com and refer to study ID # MV22430. (Identifier - NCT00927082)

Observational Cohort Study in CHB Patients Receiving Pegasys – International only
Observational study to evaluate efficacy, safety and predictors of response in CHB patients on Pegasys. Contact Hoffman-La Roche: 888-662-6728 (US only) or genentechclincaltrials@druginfo.com and refer to study ID # MV22009 (identifier - NCT01011738)

Dose Escalation of IL-7 Added to Antiviral Treatment and Vaccination in HBeAg (-) CHB – International only
Evaluate safety experimental drug, IL-7 plus Entecavir or Tenofovir and vaccine in HBeAg (-) CHB patients. Contact: Christopher Hezode at +33 14 981 2111, ext 36029. Refer to identifier – NCT01027065 (Study ID # CLI-107-10, 2009-010709-35)

NASVAC Phase-III Trial in CHB Patients – Bangladesh only
Compare therapeutic efficacy of combo therapeutic vaccine containing HBsAg, HBcAg, later called NASVAC with a commonly used antiviral drug, Peginterferon in CHB patients. Contact: Dr. Mamun Mahtab at +880 171-156-7275 shwapnil@agni.com. Refer to identifier – NCT01374308 (Study ID # NASVAC01)

Study in CHB Patients to support development of Immunological Assays – Belgium only
Develop and characterize immunological assays on blood samples. Contact: U.S. GSK at 877-379-3718 or GSKClinicalSupportHD@gsk.com and refer to identifier - NCT01098006 (Study ID # 113854)

Tenofovir in Late Pregnancy to Prevent Vertical Transmission of HBV – China
Evaluate tolerability, safety, and efficacy of reduction of HBV vertical transmission rate using Tenofovir, a pregnancy category B medication, on HBeAg+ pregnant women . Contact: Dr. Calvin Pan at +01-7188887728 cpan1135@yahoo.com or Dr. Frank Huang at +86-13533051208 frankhuangyujun@gmail.com and refer to identifier - NCT01488526 (Study ID # IN-US 174-0174)

EFFORT Extension Study (EFFORT-Ex) – China
Prove that long-term efficacy of strategy of TX adjustment at week 24 according to virological response based on ROADMAP is better than the standard care strategy and the evaluation of off-treatment durability of HBeAg seroconversion in patients who discontinued TX due to sustained HBeAg seroconversion and HBV DNA<300 cp/ml over 12 months consolidation TX. Contact: Dr. Jinlin Hou at 86-20-61641941 or jhousmu@yahoo.com.cn, or Jian Sun at 86-20-62787432 or sunjian@fimmu.com and refer to identifier - NCT01529255 (Study ID # MOH-05)

A Two-Year Study of Telbivudine in HBeAg Negative Hepatitis (STEN) – China
ROADMAP strategy provides individualized telbivudine treatment for HBeAg neg CHB patients, where telbivudine is given, but may include adding adefovir based on patient’s response. Contact: Dr. Chao-Shuang Lin at 0086(020)85252110 or linchaoshuang@yahoo.com.cn and refer to identifier - NCT01521975 (Study ID # HBeAg negative Roadmap)

Efficacy and Safety of Dual-Plasmid Hepatitis B Virus DNA Vaccine in CHB – China
Double blind, randomized, placebo controlled trial to study immunotherapeutic effects of EP mediated dual-plasmids HBV vaccine on CHB patients with ALT 2X ULN, with antiviral treatment indicated. Contact: Dr. Fuqiang Yang at 00862087376240 or yangfq23@163.com and refer to identifier - NCT01487876 (Study ID # 2011005SW0101)

HBsAg Clearance in Inactive Chronic HBsAg Carriers After Interferon Treated – China
Investigate PEG-IFN ability to achieve HBsAg loss/seroconversion in inactive carriers with persistently normal ALT, undetectable DNA and low surface antigen levels. Contact: Dr. Yao Xie at +8610-84322489 or xieyao@public.bta.net.cn and refer to identifier - NCT01471535 (Study ID # DTH-XY002)

Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With CHB Infection– China
Patients are divided into two groups: early and conventional antiviral treatment. Patients are followed for 10 yrs. to determine optimal start time for TX. Contact: Dr. Gao Zhiliang at +862085252037 Dr. Huang Zhanlian at +8685252046, Zhanlianh@21cn.com and refer to identifier - NCT00810524 (Study ID # Sun Yat-senU 5010 Hepatitis B)

Efficacy Optimizing Research of CHB Patients with Inadequate Response to NUC Therapy – China
Evaluate the efficacy and safety of generic entecavir monotherapy, or in combination with adefovir in patients with inadequate response to NUC. Contact: Dr. Jinlin Hou at 86-20-61641941, jlhousmu@yahoo.com.cn or Dr. Jian Sun at 86-20-62787432, doctorsunjian@163.com and refer to identifier - NCT01341743 (Study ID # MOH-04)

Efficacy and Safety of Telbivudine on Liver Cirrhosis in Patients with CHB – China
Antiviral treatment of CHB patients with liver cirrhosis using telbivudine. Contact: Honghao Zhang at zhanghonghao@medmail.com.cn and refer to identifier - NCT01380951 (Study ID # szwy20110610)

Therapeutic HBV Vaccine with Joint Entecavir to Treat CHB Patients – China
Evaluate efficacy & safety of therapeutic HBV vaccine (synthesized peptide) with joint entecavir treatment in CHB patients. Contact: Li Lan Juan, Fellow at 86-571-87236458 or yangyida65@163.com and refer to identifier - NCT01326546 (Study ID # 71006.04)

Influence of Hepatic Steatosis on Entecavir in CHB Patients – China
Investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in CHB patients. Contact: Dr. Xi Jin at 0086-571-87266532 or jxfl007@hotmail.com and refer to identifier -NCT01148576 (Study ID # NCTZJU201001)

Early Response to Interferon Combined with Short-Term Nucleoside Analogue Therapy in HBeAg (+) CHB– China
Interferon is used for 12 weeks at which time if HBV DNA is undetectable (<1000 copies/ml), it is continued alone for one year. If HBV DNA is still positive, nucleoside analogue is added for 3 months. After 3 months if HBV DNA is undetectable, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue. Contact: Dr. Huang Zhanlian at +86 013 58 05 84031 or email zhanlianh@21cn.com Refer to identifier - NCT00860626 (Study ID # interferonshorttermnucleoside)

Telbivudine 600 mg Tablets in Chinese Patients with CHB – China
The "Chinese PAC" study will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated CHB adults. Primary objective is the proportion of patients achieving undetectable HBV DNA at week 52. Contact: Novartis at +41 61 324 1111 and refer to identifier - NCT00781105 (Study ID # CLDT600ACN03)

Efficacy of Telbivudine Long Term in Absence of Liver Inflammation in Patients with Compensated CHB – China
Provide data on absence of inflammation in liver histology after long term telbivudine TX to determine TX discontinuation. Contact: Novartis at +41 61 324 1111 and refer to identifier – NCT00877149 (Study ID # CLDT600ACN04E1)

Resistance to Lamivudine in HBV Egyptian Patients – Egypt
On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients. Contact: Professor Mohammed Montasser at +01223363398 mfm1947@gmail.com and refer to identifier – NCT01548820 (Study ID # HBV resistance)

Evaluation of Innovative Ultrasonic Techniques for Non-Invasive Diagnosis of Liver Fibrosis in Patients with CHB or CHC (FIBRECHO) –France
Evaluation of the diagnostic performance of five innovative ultrasonic techniques for the non-invasive diagnosis of fibrosis. Contact: Dr. Vincent Leroy or Dr. Emilie Chipon at EChipon@chu-grenoble.fr and refer to identifier NCT01537965 (Study ID # DCIC 11 03)

Assess Loss of HBsAg After 48 wk. TX with PEG IFN in CHB Patients (PEGAN)–France
A randomized study to assess the loss of HBsAg after 48 week PEG IFN in patients with CHB (HBeAg negative). Contact: Dr. Marc Bourliere at +33 4 91 80 66 08 mbourliere@hopital-saint-joseph.fr or Dr. Pouget at +33 1 44 73 84 41 pouget@u707jussieu.fr and refer to identifier - NCT01172392 (Study ID # 2010-019367-11, ANRS HB 06 PEGAN)

Patients With CHB and Low Viremia Not Receiving Antiviral Therapy– Germany
An observational long-term study to evaluate demographic, clinical, histological, biochemical, and virological parameters of CHB patients with low viremia, not requiring antiviral therapy. Contact: Dr. Christoph Sarrazin at +496301 ext 5122 sarrazin@em.uni-frankfort.de and refer to identifier - NCT01090531 (Study ID # JWGUHMED1-002)

Stopping TDF TX After Long Term Virologic Suppression in HBeAg (-) CHB – Germany
Patients treated with TDF for at least 4 years, achieving and maintaining virologic suppression will be included in this two arm study to monitor for biochemical flares, possibly requiring TDF therapy restart. Contact: Dr. Lothar Gallo at +49(0)89 89 98 90 ext. 18, lothar.gallo@gilead.com, or Dr. Eduardo Martins at +1 (650) 522-5792 eduardo.martins@gilead.com and refer to identifier NCT01320943 (Study ID # GS-EU-174-0160, 2010-021925-12)

Study of Pegasys in Patients with HBeAg (-) CHB – Greece only
Observational study to evaluate factors of long-term response and safety in HBeAg (-) CHB patients on Pegasys. Contact: Hoffman-La Roche 888-662-6728 (US only) or genentechclincaltrials@druginfo.com and refer to study ID # ML22016 (identifier -NCT01283074)

Study of FG-3019 in HBV in Subjects with Liver Fibrosis Due to CHB – Hong Kong
Evaluate efficacy of FG-3019 to reverse liver fibrosis in patients with CHB starting Entecavir treatment. Contact: Dr. Dalvin Ni at dni@fibrogen.com or call 86-1390-177-2047, or Dr. Volkmar Guenzler at (415)978-1456 vguenzler@fibrogen.com, and refer to identifier – NCT01217632 (Study ID # FGCL-3019801)

Effects of Telbivudine and Tenofovir TX on the HBV DNA Kinetics in CHB – Hong Kong
Compare 12 weeks of TX with telbivudine 600 mg. plus tenofovir 300 mg. combo vs. tenofovir 300 mg. monotherapy vs. telbivudine 600 mg. monotherapy. Contact: Dr. George Lau at gkklau@netvigator.com or call +852-2855-3578 and refer to identifier - NCT00804622 (Study ID # CLDT600AHK01)

Randomized Controlled Study of Tenofovir Plus Telbivudine vs. Monotherapy with either drug in HBeAg (-) CHB patients – India
Determine efficacy and safety of combination therapy of tenofovir plus telbivudine vs. monotherapy with either drug. Contact: Dr. Manoj Kumar at +91-11-64659881, manojkumardm@gmail.com , or Dr. Tarandeep Singh at +91-11-64659881, drtarandeep@gmail.com Refer to identifier - NCT01260610 (Study ID # CLDT600AIN05T)

Telbivudine in HBeAg (+) Compensated CHB – India
Evaluate the antiviral efficacy of add-on adefovir to telbivudine in non-responders to telbivudine monotherapy after 24 and 36 initial weeks. Antiviral efficacy is assessed by HBV DNA non-detectability by week 104 with CHB. Contact: Novartis at +41 61 32 41111 and refer to identifier - NCT00537537 (Study ID #CLDT600AIN01)

Follow-Up of CHB Patients Treated with Sebivo Using the 13C Methacetin Breath Test– Israel
The Methacetin breath test will be used to assess liver function and the function of microsomal CYP4501A2, shown to correlate with degree of liver impairment and clinical outcomes for those with HBeAg neg CHB. Contact: Dr. Gadi Lalazair at +972-2-67-78511 or lalazar@hadassah.org.il and refer to identifier - NCT01204827 (Study ID # CLDT600AIL02T)

Beneficial Effect of Vitamin D Supplement to PEG IFN or Telbivudine Monotherapy in CHB Patients– Israel
The impact of Vitamin D, an important immune-modulator, has on virologic response of patients undergoing peg or nucleotide analog therapy. Contact: Dr. Assy Nimer at +97246828445 or ASSY.N@ZIV.HEALTH.GOV.IL and refer to identifier - NCT01083251(Study ID #004-10)

Phase 3 Study of GSK548470 in Patients with Compensated CHB Untreated with Nucleic Acid Analogs – Japan
Evaluate efficacy and safety of 300mg daily dose of GSK548470 in compensated CHB patients without any nucleic acid analog. Contact: US GSK Clinical Trials Call Center at 877-379-3718 GSKClinicalSupportHD@gsk.com and refer to identifier – NCT01480284 (Study ID# 115409)

Phase 3 Study of GSK548470 in Patients with Compensated CHB With Poor Response to Other Drugs – Japan
Evaluate efficacy and safety of 300mg daily dose of GSK548470 in compensated CHB patients with poor response to other drugs. Contact: US GSK Clinical Trials Call Center at 877-379-3718 GSKClinicalSupportHD@gsk.com and refer to identifier – NCT01475851 (Study ID# 115912)

Sonazoid Enhanced Liver Cancer Trial For Early Detection– Japan
Use of contrast enhanced ultrasound (US) using Sonazoid vs. conventional B-mode US for early HCC detection. Contact: Masatoshi Kudo at +81 72-366-0221 ext. 3149 or m-kudo@med.kindai.ac.jp, or Dr. Kazuomi Ueshima at +81-72-366-0221 ext. 3525, kaz-ues@med.kindai.ac.jp and refer to identifier – NCT00822991 (Study ID# JLOG08001, UMIN000001612)

Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease– Japan
Multi-center cross-sectional study using Real-time Tissue Elastography measurements prospectively from HBV/HCV patients presenting for liver biopsy. Contact: Dr. Norihisa Yada at +81 72366-0221 ext. 3525 or yada@med.kindai.ac.jp, or Dr. Kazuomi Ueshima at +81-72-366-0221 ext. 3525, kaz-ues@med.kindai.ac.jp and refer to identifier -NCT01360879 (Study ID# JLOG1002)

Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastopgraphy– Japan
Multi-center cohort study using Real-time Tissue Elastography measurements to predict the incidence of HCC and severity of ascites & decompensated cirrhosis in HBV/HCV patients. Contact: Dr. Norihisa Yada at +81 72366-0221 ext. 3525 or yada@med.kindai.ac.jp, or Dr. Kazuomi Ueshima at +81-72-366-0221 ext. 3525, kaz-ues@med.kindai.ac.jp and refer to identifier - NCT01360892(Study ID# JLOG1003)

Efficacy of Telbivudine W/ or W/out Add-on Tenofovir Compared With Tenofovir – Korea
Compare antiviral effect and mutation rate between entecavir monotherapy group and telbivudine roadmap strategy in HBeAg+ CHB patients. Contact: Dr. Ki Tae Yoon at ktyoon@pusan.ac.kr or call 82-55-360-2362 or Surin Tak surintak@hanmail.net 82-55-360-1738 and refer to identifier – NCT01588912 (Study ID # CLDT600AKR07T)

Cohort Study in Korean Patients With CHB Receiving Pegylated Interferon – Korea
Evaluation of CHB patients with genotype C on Pegasys and the durability of HBeAg seroconversion/HBsAg loss and effect on long term disease progression. Contact: Dr. Young Eun Chon at NACHIVYS@yuhs.ac or call 02-2228-1936 and refer to identifier - NCT01531166 (Study ID # 4-2011-0461)

Study with Clevudine Monotherapy or Adefovir and Clevudine Combo in CHB – Korea
Evaluate efficacy, safety and sustained effect of Clevudine vs. Adefovir + Clevudine combo in CHB patients. Contact: Dr. Byung ChulYoo at hjjang@bukwang.co.kr or call 82-2-828-8086 and refer to identifier - NCT01264133 (Study ID # CLV-411)

An Extension to Viral Kinetics Study of Telbivudine and Entecavir with CHB – Korea
Evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with CHB who have completed the CLDT600A2407 trial. Patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll in this study. Contact Novartis at +41 61 32 41111 identifier - NCT00467545 (Study ID # CLDT600AKR02)

Study of Sequential Therapy of Pegasys following Entecavir in CHB – Korea
Evaluate safety and efficacy of PEG-IFN following Entecavir vs. PEG-IFN monotherapy in HBeAg (+) patients. Contact: Joo Hyun Sohn at +82-31-560-2225 sonjh@hanyang.ac.kr or Dae-Won Jun at +82-2-2290-8338 noshin@hanyang.ac.kr Refer to identifier – NCT01220596 (Study ID # ML25206)

Switching Study From Lamivudine to Clevudine CHB Patients – Korea
Compare safety and effectiveness of switching TX from Lamivudine to Clevudine. Contact: Dr. Heon Ju Lee at mhjeong@bukwang.co.kr and refer to identifier – NCT00558493 (Study ID # KB-406)

Evaluate Efficacy and Safety of Clevudine and pegIFN in Sequence vs. Clevudine Alone or Clevudine and pegIFN Sequential in HBeAg (+) CHB Patients – Korea
Evaluate efficacy and safety of Clevudine + peg-IFN in sequence vs. Clevudine alone in CHB HBeAg(+) patients. Contact: Dr. Lee Chang Don at +82-31-820-3000 and refer identifier – NCT01264367 (Study ID # CMC-403)

Lamivudine plus Adefovir vs. Telbivudine plus Adefovir in Lamivudine Resistant CHB – Korea
Compare efficacy of continuing LAM + ADV vs. switching to Telbivudine + ADV in patients with poor response to LAM + ADV. Contact: Dr. Han Jak Ryu at +82-10-2329-2379 or hanjak@yuhs.ac or Dr. Jun Yong Park at +82-2-2228-1994 or DRPJY@yuhs.ac , and refer to identifier-NCT01270165 (Study ID # Sebivio-Ahn-01)

Development of Diagnostic Biomarker Panels for Hepatitis B and Liver Cancer – Malaysia
Develop biological markers that could be indicators for disease inducing and carcinogenic potential of the virus. Contact: Clinical Research Centre at +603-404-39300 ext. 113 shanthini@crc.gov.my and refer to identifier - NCT01310062 (Study ID # 09-317-3991)

Long Term Sustained Response of CHB Patients to Peginterferon and Relation to Genetic Variation in IL28b – Netherlands
Collect clinical and virological data on CHB patients previously treated with Peg-IFN to see if IL28B gene polymorphisms are associated with IFN response. Contact: Dr. Milan Sonneveld at m.j.sonneveld@erasmusmc.nl and refer to identifier - NCT01401400 (Study ID # HBV-10-03)

Cohort of Hepatitis B Research of Amsterdam – Netherlands
Observational cohort study to determine whether historic HBV viral load is associated with the risk of HBV related cirrhosis or mortality in a cohort of non-Asian individuals with CHB. Contact Dr. Soeradj Harkisoen at +31 88 7556228 or s.harkisoen@umcutrecht.nl and refer to identifier - NCT01462981 (Study ID # COBRA)

HBsAg Loss in CHB Patients with Low Viral Load – Netherlands
Investigate proportion of HBeAg negative, inactive carriers (DNA < 20K IU/ml) who will lose HBsAg when treated with PEG +Adefovir, or PEG + Tenofovir. Contact Dr. Henk Reesink at +31 20 5662787 or h.w.reesink@amc.nl, or Dr. Annikki de Niet at +31 20 5668278 a.deniet@amc.nl and refer to identifier - NCT00973219 (Study ID # TTM16002, ABR no.: 28338)

Study to Assess DV-601 in Subjects with CHB – Poland
Determine if DV-601, a therapeutic vaccine, will be well tolerated and induce virological and immunological response in CHB patients. Contact: Dr. K. Majorowski at +48 22 544 1756 or kmajorowski@grs-cro.com and refer to identifier – NCT01023230 (Study ID # DV4-HBT-02, 2009-010142-66)

HBV Kinetics During Treatment with Telbivudine – Spain
Prospective study to explore HBV kinetics in CHB during the first 24 weeks of treatment with telbivudine. Contact: Novartis at +41 61 3241111 and refer to identifier - NCT00640588 (Clinical Study # CLDT600AES01)

Telbivudiune vs. Lamivudine for Maintenance Therapy of CHB and Neg HBV DNA Viral Load After 6 Months TX with Telbivudine – Switzerland
Show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine for patients showing no viral load after 24 week telbivudine treatment vs continuous treatment with telbivudine TX.. Contact: Markus Heim at +41 61 265 25 25 or markus.heim@unibas.ch or Michael Dill at +41 61 265 25 25 Michael.Dill@unibas.ch and refer to identifier - NCT01005238(Clinical Study # SASL28)

Tenofovir in Chronic Hepatitis B With Mild ALT Elevation –Taiwan
Clarify whether CHB patients with high viral load will benefit from oral anti-viral therapy despite only mildly elevated serum liver enzymes. Contact: Dr. Jaw-Town Lin +886-2-23123456 ext 62246 or email jawtown@ntu.edu.tw or Dr. Yao-Chun Hsu at +866-7-6150011 ext 2980 and refer to identifier NCT01522625 (Study ID # EMRP36100N)

Acoustic Radiation Force Impulse (ARFI) Technology in Prediction of Liver Fibrosis –Taiwan
Complete correlation and validity studies for liver fibrosis staging between ARFI elastosonography quantification and METAVIR by liver biopsy in CHB patients. Contact: Dr. Sheng-Hung Chen 886-4-22052121 ext 2264 shcvghtc@gmail.com and refer to identifier NCT01268865 (Study ID # DMR99-IRB-240)

Antiviral Therapy in Pregnant Women to Reduce Mother-to-Infant Transmission of HBV–Taiwan
Trial using tenofovir to reduce mother-to-infant transmission of HBV and to monitor status of mother and infant. Infants to receive vaccine and HBIG. Contact: Dr. Mei-Hwei Chang 886-02-23123456 ext 71723 changmh@ntu.edu.tw or Dr. Huey-Ling Chen at 886-02-23123456 -ext. 71722 hueyling@ntu.edu.tw and refer to identifier - NCT01312012 (Study ID # 201010078M)

Study of Telbivudine in CHB –Taiwan
Evaluate the safety, tolerability and antiviral efficacy of telbivudine by maintained suppression of HBV DNA (<=60 IU/ml) in HBeAg (+)/(-) patients at physician’s general practice. Contact: Hsiang-min Kung +886-3-3281200 ext 2224 or email hsiang0721@gmail.com and refer to identifier NCT00970216 (Study ID # PMST-Y-1)

Prednisolone Priming Study in Patients with CHB –Taiwan
Investigate whether ALT rebound following corticosteroid priming enhances response to telbivudine therapy. Contact: Mei-Hsia Ku +886-3-3281200 ext 8114 or email kuvicky1029@gmail.com and refer to identifier - NCT00778596 (Study ID # CST-L-1)

Pegasys in Combination with Adefovir or Entecavir in HBeAg (+) CHB –Taiwan
A 3 arm study will assess the efficacy and safety of PEGASYS alone or in combination with Adefovir or Entecavir in patients with HBeAg (+) CHB. Contact: Hoffmann-La Roche at 888-662-6728 (US only) and genentechclinicaltrials@druginfo.com and refer to Study ID # ML21827. (Identifier - NCT00922207)

Pegasys Plus Entecavir vs. Entecavir only for HBeAg (+) CHB – Taiwan
Evaluate combo therapy of Pegasys plus Entecavir vs. Entecavir alone for HBeAg (+) CHB Patients. Contact: Dr. Pei-Jer Chen at 886-2-231-23456 ext 7072 or peijerchen@ntu.edu.tw, or Chun-Jen Liu 886-2-23-123456 ext 6644 cjliu@ntu.edu.tw , and refer to identifier – NCT00597259 (Study ID # 200710028M)

Entecavir with Pegasys Sequential Therapy vs. Pegasys for HBeAg (+) CHB –Taiwan
A placebo controlled randomized study to evaluate if adding entecavir early in the course of therapy or extending the treatment duration of peginterferon alfa-2a can improve the treatment response. National Taiwan University Hospital: Contact Dr. Chen-Hua Li at 886-2-23123456 ext 63572 jacque_liu@mail2000.com.tw or Dr. Jia-Horng Kao at 886-2-23123456 ext. 67307 kaojh@ntu.edu.tw and refer to identifier - NCT00921180 (Study ID # 950922)

Entecavir with Pegasys Sequential Therapy vs. Pegasys for HBeAg (-) CHB –Taiwan
A placebo controlled randomized study to evaluate if adding entecavir early in the course of therapy or extending the treatment duration of peginterferon alfa-2a can improve the treatment response for HBeAg (-) patients. Contact Dr. Chen-Hua Liu at 886-2-23123456 ext 63572 jacque_liu@mail2000.com.tw or Dr. Jia-Horng Kao at 886-2-23123456 ext. 67307 kaojh@ntu.edu.tw and refer to identifier – NCT00917761 (Study ID # 950924)

PEG-IFN Monotherapy vs. Combination with Entecavir in HBeAg (-) CHB –Thailand
Determine if combination of PEG-IFN and entecavir improves response and HBsAg clearance in HBeAg (-) patients vs. PEG-IFN alone. Contact Dr. Pisit Tangkijvanichat +662-256-4482 pisittkvn@yahoo.com and refer to identifier NCT01243281 (Study ID # Biochem2010/01)

HBV CO-INFECTION TRIALS

*CHB=Chronic hepatitis B

Lonafarnib for Chronic Hepatitis D –U.S. only
Study different doses of lonafarnib for those coinfected with HBV and HDV to see how it affects virus levels and other symptoms of HDV. Contact: Vanessa Haynes-Williams, RN at 301-402-0267 vhaynes@mail.nih.gov or Dr. Theo Heller at 301-402-7147 Theoh@mail.nih.gov Refer to identifier NCT01495585 (Study ID # 120046, 12-DK-0046)

Long-term Study of Liver Disease in Patients with HBV and/or HCV with or w/out HIV – U.S. only
Study to understand how these viruses affect the immune system over the long-term. Annual visit with researcher, but patient must have a primary care doctor. Contact: Colleen Kotb, RN 202-857-7652, kotbch@mail.nih.gov or Dr. Shyamasundaran Kottilil at 301-435-0936 skottilil@niaid.nih.gov . Refer to identifier - NCT01350648 (Study ID # 110152, 11-CC-0152)

A Study of Maraviroc in HIV Co-infected Subjects with HCV and/or HBV –U.S. and International
Describe liver enzyme elevations in patients who are coinfected with HIV and either HCV and/or HBV receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy. Contact: Pfizer CT.gov Call Center 1-800-718-1021. Refer to identifier NCT01327547 (Study ID # A4001098)

Innate Immunity in HIV Positive Patients co-Infected with HCV or HBV –Australia
Data from this study will provide the first information on how the innate immune system may be altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor changes with HIV co-infection therapy. Contact: Jennifer Audsley, PhD (Monash University) at jennifer.audsley@med.monash.edu.au (Refer to identifier -NCT00662194 (Study ID # ALF-55/08)

Surveillance Program for the Detection of HBV Resistance to Tenofovir in HIV-HBV Co-Infected Patients –Australia
Identify any changes in the HBV DNA that might be associated with resistance to tenofovir (TDF), to determine how long any changes take to occur and to determine the effect of these changes on the clinical response to TDF in HIV-HBV co-infected patients. Contact Jennifer Audsley, PhD at +61399030184 or jennifer.audsley@med.monash.edu.au (Refer to identifier - NCT00660361) (Study ID # ALF-55/08)

PEDIATRIC HBV CLINICAL TRIALS

*CHB=Chronic hepatitis B

Hepatitis B Research Network Pediatric Cohort Study (HBRN) – U.S. and Canada
Study children between 6 months and < 18 yrs. with HBV and identify predictors of disease activation and progression. Contact: NIKKD of NIH and refer to contacts at individual locations by identifier – NCT01263600 (Study ID # DK082864Pediatric, U01DK082864)

Single-Dose Telbivudine in Children and Adolescents with CHB –International only
Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with CHB. Contact: Novartis at +41 61 324 1111. Refer to identifier- NCT00907894 (Study ID #CLDT600A2104, EudraCT 2007-006218-40)

Entecavir in Pediatric Patients with CHB –U.S. and International
Determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied. For participation in the U.S., call trial site phone no. For site info outside the U.S., email Clincal.Trials@bms.com. First line of email MUST contain NCT# & Site#. Refer to identifier - NCT00423891 (Study ID # AI463-028)

Phase III Study of Safety and Efficacy of Entecavir in Pediatric Patients with CHB –U.S. and International
Determine the safety and efficacy of entecavir in pediatric patients with CHB. Contact: In the U.S., refer to site specific phone no.. For info outside the U.S., email - Clinical.Trials@bms.com with first line containing NCT# & Site#. Refer to identifier - NCT01079806 (Study ID # AI463-189)

HBV AND LIVER TRANSPLANTATION CLINICAL TRIALS

*CHB=Chronic hepatitis B

Evaluation of HepaGam B in Combo with antivirals in HBV liver transplants - U.S. only
Assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of HBV reoccurrence following liver transplantation. Contact: Dr. Christine Hall at 204-275-4248 or chall@cangene.com, or Priya Uppin, MSc at 204-275-4531 puppin@cangene.com and refer to identifier – NCT00722332 (Study ID # HB-009)

Evaluating Blood Glucose during HBIG Infusion in Post Liver Transplant Patients -U.S only
Determine if use of HBIG post-transplant shows an increase in glucose using specific vs. non-specific glucose monitoring. Contact: Anna Argyris at 202 444-3700. Refer to identifier – NCT00998426 (Study ID # 2009-337)

Prophylaxis of HBV recurrence after Liver Transplantation -China
Evaluate Entecavir + HBIG vs. Lamivudine + HBIG vs. Adefovir + HBIG in HBV Transplant Patients. Contact: Dr. Zhi-Hai Peng at 0086-021-63240090 ext 3132 or pengpzh@hotmail.com or Dr. Tao Li 0086-021-63240090 ext. 3136 transplant@126.com and refer to identifier – NCT01139203 (Study ID # SH20100601)

Prevention of HBV Reinfection Post Liver Transplant via Entecavir -Germany
Determine if HBIG can be stopped early and replaced with Entecavir following HBV-induced liver transplantation to prevent reinfection. Contact: Dr. M. Manns at +495115320 ext 3305 or manns.michael@mh-hannover.de and refer to identifier – NCT01046799 (Study ID # 2008-005976-28)

Niuliva® for the Prevention of HBV Recurrence in Orthotopic Liver Transplant Recipients– Italy
Evaluate efficacy & safety of HBV immune globulin in the prophylaxis of HBV reinfection of HBV liver recipients, maintaining HBsAb levels for first six months post-transplant. Contact: Antonio Paez, MD at +34 935710700 or antonio.paez@grifols.com, or Michael Woodward at +34 935710700 mwoodward@grifols.com and refer to identifier - NCT01131065 (Study ID # IG 0907)

Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients -Korea
Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation. Contact: SKchemicals Clinical research team at +82-2-2008-2008 and refer to identifier – NCT01513850 (Study ID # Hepabulin IV_LTIII_2011)

HBV AND LIVER CANCER (or HEPATOCELLUAR CARCINOMA, HCC)

*CHB=Chronic hepatitis B

Viral & Host Factors Associated with HBV-related HCC – U.S. only
Sequence HBV genome in CHB patients and those with HCC due to CHB and identify mutations in HBV genome to determine risk factors. Contact: Mei-Sze Chua at 650-724-3525 or mchua@standford.edu and refer to identifier – NCT00767936 (Study ID # SU-05222008-1183, 98795, HEP0013)

Sorafenib Tosylate With or Without Everolimus in Treating Patients with Localized, Unresectable Metastatic Liver Cancer – International only
Phase II trial of sorafenib plus everolimus vs. sorafenib alone to treat patients with localized, unresectable, or metastatic liver cancer. Contact: Refer to site location contact information with identifier – NCT01005199 (Study ID # CDR0000657702, SWS-SAKK-77/08, EUDRACT-2009-011884-35)

Risk of Exacerbation of CHB after Percutaneous Radiofrequency Ablation of HCC – China
Risk of exacerbation of CHB after RAF or hepatomy for HCC and effects on treatment outcome. Contact: Dr. Min-Shan Chen at 86-20-87343117 or Chminsh@mail.sysu.edu.cn and refer to identifier – NCT00720668 (Study ID # RFA006)

Efficacy of Antiviral Therapy After Radical Resection for HBV-related HCC – China
Antiviral treatment with Lamivudine or Entecavir following radical resection of HBV-related HCC. Contact: Dr. Xiang-Ming Lao at 86-20-87343115 or laoxming@mail.sysu.edu.cn and refer to identifier – NCT00768157) (Study ID # SYSUCC-HCC004)

HCC Treatment Using Transcatheter Arterial Chemoembolization (TACE) with Anti-HBV Therapy (TACEHBV) –China
Influence of anti-HBV therapy (Telbivudine) on safety and survival of HCC patients after TACE. Contact: Dr. Jinglin Xia at xia.jinglin@zs-hospital.sh.cn or Dr. Biwei Yang at yang.biwei@zs-hospital.sh.cn and refer to identifier – NCT01102335 (Study ID # LCI-001)

TACE and Adefovir Compared with Transcatheter Arterial Chemoembolization (TACE) Alone for HBV Related Unresectable HCC –China
Influence of TACE plus adefovir vs. TACE alone on those CHB patients with unresectable HCC. Contact: Dr. Daoyuan Wang +86 21 6630058 ghealth2008@gmail.com and refer to identifier – NCT00960518 (Study ID # SHDSYY20090725)

A Randomized Study Comparing Lamivudine vs. Adefovir for Prevention of HBV Reactivation in HBsAg+ Patients on Chemo –Hong Kong
Open label study for HBsAg (+) patients undergoing chemotherapy to receive lamivudine or adefovir during TX. Contact: Dr. Chee-Kin Hui at 852-2818 4300 ckh23@hku.hk and refer to identifier – NCT00489151 (Study ID # UW 04-315 T/637, HARECCTR0500002)

Dose Escalation Trial of Radiation Therapy (RT) for HCC – Taiwan
Determine max. tolerated dose of RT, and evaluate tumor control, patterns of failure and survival for those HBV carriers with HCC. Contact: Dr. Jason Chia-Hsien Cheng at 886-2-23123456 ext. 66696 or jasoncheng@ntu.edu.tw and refer to identifier – NCT00960167 (Study ID # 200906051R)

HBV REACTIVATION AND LYMPHOMA

*CHB=Chronic hepatitis B

Factors Influencing HBV Reactivation in Lymphoma Patients Treated with Rituximab – International only
Identify factors influencing HBV reactivation in patients treated with rituximab. Contact: Dr. Seok Jin Kim at 822-34101766 kstwoh@skku.edu and refer to identifier – NCT01311232 (Study ID # 2010-11-035)

Reactivation in HBsAg (-)/HBcAb(+) Lymphoma Patients Treated with RCHOP (IHBVRL) – China only
Identify incidence of HBV reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma with prior HBV undergoing RCHOP immuno-chemotherapy. Contact: Dr. Dongmei Ji at 86-21-64175590 ext. 8908, jidongmei2000@hotmail.com and refer to identifier – NCT01210287 (Study ID # 201010HBV)

Activation of HBV in HBsAg (-) But Anti-HBc Postive Patients – Japan only
Observational study to determine risk factors and strategies for individuals with resolved HBV (HBsAg (-) and Anti-HBc) and malignancy. Contact: Dr. Yoshihide Ueda at 81-75-751-3111 yueda@kuhp.kyoto-u.ac.jp and refer to identifier NCT00881036 (Study ID # HBV from anti-HBc positive)

Prophylactic Use of Entecavir for Non-Hodgkin’s Lymphoma Patients with Resolved HBV (HBVNHL) – Taiwan only
Prophylactic use of entecavir for patients with resolved HBV undergoing chemo for non-Hodgkin’s lymphoma. Contact: Dr. Yi-Hsiang Huang at 886-2-287-12121 ext 3352 yhhuang@vghtpe.gov.tw and refer to identifier – NCT00926757 (Study ID # VGHUST98-P1-07, VGHIRB98-01-08)

Page last modified May 2, 2012