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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 December 29, 2011

U.S. CLINICAL TRIALS

*CHB=Chronic hepatitis B

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:  Patient Recruitment and Public Liaison Office (NIDDK) prpl@mail.cc.nih.gov  or call 800-411-1222, or 1-866-411-1010. 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:  Patient Recruitment and Public Liaison Office (NIDDK) prpl@mail.cc.nih.gov  or call 800-411-1222, or 1-866-411-1010. 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:  Patient Recruitment and Public Liaison Office (NIDDK) prpl@mail.cc.nih.gov  or call 800-411-1222.  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: Patient Recruitment and Public Liaison Office at (800) 411-1222 or prpl@mail.cc.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 Dr. Eduardo Martins at 650-522-5792 - Eduardo.Martins@gilead.com or Dr. Uri Lopatin at 650-522-5120 - uri.lopatin@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

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:  Patient Recruitment and Public Liaison Office (NIDDK) prpl@mail.cc.nih.gov  or call 800-411-1222, or 1-866-411-1010. Refer to identifier - NCT01306071 (Study ID # 110108, 11-DK-0108)

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)

Study of Entecavir Plus Tenofovir in CHB Patients Who Failed Previous Treatment –International only
Show that combination of Entecavir and Tenofovir is safe, tolerated and effective for CHB patients who failed previous TX. Contact: Clinical.Trials@bms.com and refer to identifier -NCT01063036 (Study ID # Al463-203, 2009-015705-40) First line of email MUST contain NCT# & site #.

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)

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)

Effects of Telbivudine and Tenofovir Treatment on HBV DNA Kinetics in CHB – China
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:  Novartis at +41 61 3241111 and refer to identifier - NCT00805675  (Study ID # CLDT600AHK01)

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, sunjian@fimmu.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 (+) CHBChina
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)

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. GadiLalazair 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. NorihisaYada 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)

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. HeonJu 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)

Double-Blind Randomized Trial Comparing Safety and Antiviral Activity of 48-Week Clevudine and AdefovirDipvoxil in HBeAg (-) CHB Patients with Compensated Liver Function – Korea
Compare the safety and antiviral activity of 48 week Clevudine and Adefovirdipivoxil in HBeAG(-) CHB with compensated liver function.  Contact: Dr. Hyo-Suk Lee at +82-2-828-8082 and refer to identifier – NCT00641082   (Study ID # CLV-401)

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)

PEG-IFN in HBV Patients with Incomplete Response to NA (PADD) – Netherlands