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

Sponsor:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00507689

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 plus Hepatitis B Immunoglobulin Drug: emtricitabine/tenofovir disoproxil fumarate	Phase II

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B Liver Transplantation

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Immunoglobulins Recombinant hepatitis B vaccine Truvada Hepatitis B hyperimmune globulin Hepatitis B Vaccines Hepatitis A Vaccines Globulin, Immune

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 ]

Estimated Enrollment:	50
Study Start Date:	August 2007
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	January 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 plus Hepatitis B Immunoglobulin emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg fixed dose combination tablet given orally once daily Hepatitis B Immunoglobulin will be given (either IV or IM) at a dose and frequency per the investigative site protocol Other Name: Truvada plus 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 Medical Center

More Information

No publications provided

Responsible Party:	Stephen Rossi, PharmD/ Sr. Director, Clinical Research, 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:	January 5, 2011
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 disoproxil
Tenofovir
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 February 12, 2012