Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: FTC/TDF (Drug); Hepatitis B Immunoglobulin (HBIg) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s): Lewis Teperman, MD, Principal Investigator, Affiliation: New York University School of Medicine
Summary
The objective of this 96-week study was to evaluate the safety and antiviral efficacy of
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or
without hepatitis B immunoglobulin (HBIg) in preventing the recurrence of chronic hepatitis
B following liver transplantation, in participants who were chronically infected with
hepatitis B prior to transplantation.
Prior to enrollment, participants were required to have received at least 12 weeks of HBIg
therapy following liver transplantation. Enrolled participants then received FTC/TDF plus
HBIg for an initial 24-week pre-randomization treatment period. Participants who completed
the pre-randomization period and who achieved sustained viral suppression were randomized to
continue treatment with FTC/TDF with or without HBIg for an additional 72 weeks (randomized
period). The antiviral efficacy of treatment was assessed by measuring hepatitis B virus
levels in the blood (HBV DNA). Safety and tolerability was monitored by assessing adverse
events and various laboratory parameters.
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Percentage of Participants With HBV Recurrence Prior to or at Week 72
Secondary outcome: Percentage of Participants With HBV Recurrence at Week 96Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72 Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96 Percentage of Participants With Normal ALT at Week 72 Percentage of Participants With Normal ALT at Week 96
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult subjects (18-75 years of age) with either hepatitis e antigen (HBeAg) positive
or HBeAg negative chronic HBV prior to transplant
- Willing and able to provide written informed consent
- Subjects with detectable antibody to hepatitis B surface antigen performed by a local
laboratory result within 30 days of screening
- Subjects must have been stable and may not have had 2 or more of the following
laboratory parameters associated with decompensated liver disease: conjugated
bilirubin > 1. 5 x the upper limit of the normal range (ULN), prothrombin time > 1. 5 x
ULN, platelets < 60,000/mm^3, serum albumin < 3. 0 g/dL
- Must have had at least 12 weeks of center-specific prophylactic therapy including
hepatitis B immunoglobulin (HBIg) posttransplant
- Calculated creatinine clearance ≥ 40 mL/min using the Cockcroft-Gault equation
- No significant evidence of ongoing deterioration of renal function
- Negative serum beta-human chorionic gonadotropin (for females of childbearing
potential only)
Exclusion Criteria:
- Subjects with HBV recurrence, ie, confirmed HBV DNA ≥ 400 copies/mL, following liver
transplant
- Pregnant women, women who were breast feeding or who believed they may have wished to
become pregnant during the course of the study
- Males and females of reproductive potential who were 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), eg, alpha-fetoprotein > 50 ng/mL, or by
any other standard of care measure or presence of multifocal HCC at the time of
transplantation if transplantation was within 144 weeks of screening
- Prior TDF or FTC/TDF experience post-transplant or > 12 months treatment with TDF or
FTC/TDF treatment pretransplant
- Coinfection with hepatitis C virus (by serology), HIV, or hepatitis D virus
pretransplant or at screening
- Significant renal, cardiovascular, pulmonary, or neurological disease
- Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
- Were likely to receive systemic drugs with nephrotoxic potential, except
immunosuppressive agents (eg, cyclosporine, tacrolimus), during the course of the
study
- History of variceal bleeding or hepatic encephalopathy following orthotopic liver
transplantation
Locations and Contacts
Los Angeles, California 90048, United States
San Francisco, California 94115, United States
San Francisco, California 94143, United States
Atlanta, Georgia 30322, United States
Chicago, Illinois 60608, United States
New York, New York 10016, United States
New York, New York 10029, United States
Additional Information
Starting date: September 2007
Last updated: February 12, 2014
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