HBV and Chemotherapy or Immune-Suppressing Drugs

*CHB=Chronic hepatitis B

For trials listed as "International" or "International Only," click on the NCT identification number for a complete list of participating countries.

Abatacept vs Placebo in RA Patients w/ Hepatitis B on Entecavir Background -U.S.
Purpose is to investigate whether the combination of abatacept along with entecavir is safe and effective in treating symptoms of Rheumatoid Arthritis. Contact: Bal-lan Yen at 310-206-4112 or byen@mednet.ucla.edu or Gabriel Valdivia at 310-794-9504 or gvaldivia@mednet.ucla.edu and refer to identifier – NCT02053727 (Study ID # IM101329, 13-001279)

Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy – U.S.
Goal is to learn about testing patients for viral infections prior to chemotherapy. Contact: Dr. Jessica P. Hwang at 713-745-4516 and refer to identifier – NCT01970254 (Study ID # 2012-0961, 1R21CA147202-01A1)

Tenofovir to Prevent HBV Reactivation -Canada
Determine effectiveness of preemptive tenofovir therapy in preventing reactivation of hepatitis B in patients receiving rituximab-based chemotherapy for Non-Hodgkin’s Lymphoma as compared to patients receiving tenofvir as needed. Contact: Dr. Jordan Feld at 416-603-5914 ext 2684 Jordan.feld@uhn.ca or Victor Lo at 416-603-5839  victor.lo@uhn.ca and refer to identifier – NCT02186574 (Study ID # JF62014)

Prophylactic Use of Entecavir for HBsAg (+) Lymphoma Patients with Rituximab based Immunochemotherapy – China 
Identify the effect of prophylactic entecavir in HBsAg positive lymphoma patients treated with rituximab-based immunochemotherapy and or chemotherapy.    Contact: Jun Zhu at zj@bjcancer.org or Yuqin Song at songyuqin622@sina.com and refer to identifier – NCT01768195 (Study ID # PKU-2012111304)

Prophylactic Use of Entecavir for HBsAg (-)/HBcAb (+)/Hepatitis B Virus DNA (-) with Lymphoma – China
Identify the effect of prophylactic entecavir in HBsAg negative/HBcAb positive/hepatitis B virus DNA negative patients with lymphoma.  Contact: Jun Zhu at zj@bjcancer.org or Yuqin Song at songyuqin622@sina.com and refer to identifier – – NCT01765231 (Study ID # PKU-2012111305)

Prophylactic or Preemptive Entecavir in Patients With Gastric Cancer Who Are Inactive Hepatitis B Carriers -- China
This open, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug entecavir on the outcomes of patients with gastric cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups. Contact: Rui Hua Xi at 86 13922206676 or xurh@sysucc.org.cn and refer to identifier NCT02777801.

Is Hepatitis B Surface Antigen (HBsAg) Enough Alone as a Screening Test Before Immunosuppressive Therapies? – Egypt
After acute hepatitis B, the disappearance of hepatitis B surface antigen (HBsAg) is believed to signify viral elimination. However, these subjects may have occult HBV infection. Occult HBV infection usually accompanies antibody against hepatitis B core antigen (anti-HBc) and/or antibody against HBsAg (anti-HBs), but some cases might not have these serological markers.This study screens for occult hepatitis B before immunosuppressive treatment for rheumatic disease. Contact: Sherief Abd-Elsalam at 00201095159522 or sheriff_tropical@yahoo.comand refer to identifier NCT02799316.

Efficacy and Safety of Ibrutinib in Patients With CLL and Other Indolent B-cell Lymphomas Who Are Chronic Hepatitis B Virus Carriers or Occult Hepatitis B Virus Carriers – Hong Kong
The clinical benefit of ibrutinib has been demonstrated in patients with lymphocytic leukemia, some lymphomas and other B-cell non-Hodgkin lymphomas. The pivotal trials of ibrutinib excluded HBsAg+ patients. Therefore, the effects of ibrutinib on HBsAg+ and anti-HBc+ patients remain entirely undefined. To enable ibrutinib to be prescribed in Asia and other regions of the world where HBV is endemic, a total of 62 patients will be recruited, including 16 HBsAg+ patients, and 46 occult HBV carriers. Contact King Hei Lum NNedSc at 852 22554361 ext 1654 or email khlu@khu.hk and refer to identifier NCT02991638.

Optimizing HBV Management During Anti-CD20 Antibodies – Hong Kong
Hepatitis B virus (HBV) reactivation is common during anti-CD20 containing chemotherapy, even in HBsAg-negative patients with only prior HBV exposure. The optimal timing of commencing antiviral therapy and the interval of clinical monitoring is uncertain. One-quarterof the Hong Kong population has prior HBV exposure. We plan monitor this cohort of patients and determine (1) the optimal time point for starting antiviral therapy based on the progression of HBV reactivation, and (2) the optimal interval of clinical monitoring. Contact: Wai-Kay Seto, MD, at 85222553994 or email wkseto@hku.hk and refer to identifier NCT03155984.

Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure –India
Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre cirrhotic,compensated, decompensated and reactivation). All the in and out patient with Hepatitis B reactivation will be recruited and randomized into two arms.Tenofovir with FMT (Fecal Microbiota Transplant) would be given to one arm, and tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days. Contact: Dr. Juned Ahmad at ahmadjuned43.jk@gmail.com and refer to identifier NCT02689245.

Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: ENT vs. LAM – Korea 
Compare the effect of entecavir (ENT) versus lamivudine (LAM) to prove the superiority of entecavir over lamivudine for the prevention of reactivation of HBV in HBsAg positive patients undergoing cytotoxic chemotherapy. Contact: Dr. Sook-Hyang Jeong +82 31 787-7034 jsh@snubh.org and refer to identifier – NCT01580202 (Study ID # Al463-246)

To Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma – Korea
The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV) reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with rituximab and compare HBV reactivation rates by duration of prophylactic treatment with tenofovir to contribute to the establishment of an effective prevention strategy. Contact: Yoon Jun Kim, PhD, MD, 822 2072 3081 or email yoonjun@snu.ac.kr and refer to identifier NCT02585947

Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients - Taiwan
The main goal of the study is to identify the incidence of HBV reactivation during and after biologic treatment in rheumatoid arthritis (RA) patients who are inactive HBV carriers or have past HBV infection, and try to define the optimal HBV monitoring and antiviral prophylactic strategy in RA patients. Contact: Chieh-Ju Lee at +886-2-28712121 ext 2972 at Taipei Veterans General Hospital and refer to identifier -- NCT01907230 (Study ID AI463-962).

Prophylactic or Preemptive Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers – Taiwan
This open, randomized controlled clinical trial compares the impact of the prophylactic use or preemptive use of the antiviral drug entecavir on the outcomes of patients with colorectal cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups. Contact: Dr. Rui Hua at xurh@sysucc.org.cn or 86-20-87343295 and refer to identifier NCT02777814.

Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan (Yervoy RMP) – Taiwan
This trial is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable, recurrent or metastatic) melanoma. Contact: Bristol-Myers Squibb at Clinical.Trials@bms.com and refer to identifier NCT02402699.