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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 96

Percentage 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

Page last updated: August 20, 2015

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