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Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIG) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00507689
First received: July 25, 2007
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B
 Drug: emtricitabine/tenofovir disoproxil fumarate
Drug: Hepatitis B Immunoglobulin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Recurrence of Chronic Hepatitis B virus post liver transplant [ Time Frame: 1.5 to 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: August 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
emtricitabine/tenofovir disoproxil fumarate plus Hepatitis B Immunoglobulin
 Drug: emtricitabine/tenofovir disoproxil fumarate
emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg fixed dose combination tablet given orally once daily
Other Name: Truvada
Drug: Hepatitis B Immunoglobulin
Hepatitis B Immunoglobulin will be given (either IV or IM) at a dose and frequency per the investigative site protocol
Other Name: HBIG
Experimental: B
emtricitabine/tenofovir disoproxil fumarate
 Drug: emtricitabine/tenofovir disoproxil fumarate
emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg fixed dose combination tablet given orally once daily
Other Name: Truvada

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507689

Locations
United States, California
Los Angeles, California, United States, 90048
San Francisco, California, United States, 94143
San Francisco, California, United States, 94115
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, New York
New York, New York, United States, 10029
New York, New York, United States, 10016
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Lewis Teperman, MD New York University School of Medicine
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00507689     History of Changes
Other Study ID Numbers: GS-US-203-0107
Study First Received: July 25, 2007
Last Updated: May 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Truvada
HBIG
Chronic Hepatitis B Recurrence
Post Orthotopic Liver Transplant

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Recurrence
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
 Disease Attributes
Pathologic Processes
Immunoglobulins
Antibodies
Tenofovir
Tenofovir disoproxil
Emtricitabine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on May 23, 2013