Truvada Versus Truvada Plus HBIG in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: emtricitabine/tenofovir disoproxil fumarate plus Hepatitis B Immunoglobulin (Drug); emtricitabine/tenofovir disoproxil fumarate (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s):
Lewis Teperman, MD, Principal Investigator, Affiliation: New York University Medical Center
Overall contact:
Jane Anderson, PhD, Email: jane.anderson@gilead.com
Summary
The objective of this study is to evaluate the safety and antiviral efficacy of the
combination therapy (emtricitabine/tenofovir disoproxil fumarate), plus or minus Hepatitis B
Immunoglobulin (HBIG) in preventing the recurrence of chronic hepatitis B after a patient
(who was chronically infected with hepatitis B pre-liver transplant) has undergone a liver
transplant.
Clinical Details
Official title: A Phase 2, Open-Label Randomized Study to Evaluate the Efficacy and Safety of the Combination Product, Emtricitabine/Tenofovir Disoproxil Fumarate in the Presence or Absence of Hepatitis B Immunoglobulin (HBIG) in Preventing Recurrence of Chronic Hepatitis B (CHB) Post-Orthotopic Liver Transplant (OLT)
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Recurrence of Chronic Hepatitis B virus post liver transplant
Detailed description:
After a minimum of 9 months of HBIG treatment plus oral anti-HBV therapy (3 months prior to
study entry and 6 months on study) patients are randomized to discontinue HBIG and continue
emtricitabine/tenofovir DF only or to continue on HBIG plus emtricitabine/tenofovir DF. The
antiviral efficacy of treatment will be assessed by measuring virus levels in the blood (HBV
DNA). Safety and tolerability will be monitored by assessing adverse events and various
laboratory parameters.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult subjects (18-75 years of age) with either HBeAg positive or HBeAg negative CHB
prior to transplant
- Willing and able to provide written informed consent
- Subjects with detectable anti-HBs (by a local laboratory result within 30 days of
screening)
- Subjects must be stable and may not have 2 or more of the following laboratory
parameters associated with decompensated liver disease: e. g., conjugated bilirubin
>1. 5 X ULN, PT > 1. 5 X ULN, platelets < 60,000/mm3, serum albumin < 3. 0 g/dL
- Must have had at least 12 weeks of center specific prophylactic therapy including HBIG
post-transplant
- Calculated creatinine clearance (CLcr) >= 40 mL/min using the Cockcroft- Gault
equation
- No significant evidence of ongoing deterioration of renal function.
- Negative serum beta-HCG (for females of childbearing potential only)
Exclusion Criteria:
- Subjects with CHB recurrence, i. e., confirmed HBV DNA >= 400 copies/mL, post liver
transplant
- Pregnant women, women who are breast feeding or who believe they may wish to become
pregnant during the course of the study.
- Males and females of reproductive potential who are unwilling to use an "effective"
method of contraception during the study and for at least 30 days from the date of
last dose of study drug.
- Evidence of hepatocellular carcinoma (HCC), e. g., alpha-fetoprotein > 50 ng/mL or by
any other standard of care measure or presence of multifocal HCC at the time of
transplantation
- Prior tenofovir DF or emtricitabine/tenofovir DF experience post-transplant or > 12
months treatment with tenofovir DF or emtricitabine/tenofovir DF treatment pre
transplant
- Co infection with HCV (by serology), HIV, or HDV pre-transplant or at screening.
- Significant renal, cardiovascular, pulmonary, or neurological disease.
- Known hypersensitivity to the study drugs, the metabolites or formulation excipients
- Likely to receive systemic drugs with nephrotoxic potential, except immunosuppressive
agents (e. g., cyclosporine, tacrolimus), during the course of the study.
- History of variceal bleeding or hepatic encephalopathy post OLT
Locations and Contacts
Jane Anderson, PhD, Email: jane.anderson@gilead.com
Los Angeles, California 90048, United States; Recruiting
San Francisco, California 94143, United States; Recruiting
San Francisco, California 94115, United States; Recruiting
Atlanta, Georgia 30322, United States; Recruiting
New York, New York 10029, United States; Recruiting
New York, New York 10016, United States; Recruiting
Additional Information
Starting date: August 2007
Ending date: July 2011
Last updated: August 27, 2008
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