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A Study to Compare Tenofovir Versus the Combination of Tenofovir Plus Emtricitabine for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00507507
First received: July 25, 2007
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

The main objective of the study is to evaluate the antiviral activity of tenofovir monotherapy versus tenofovir plus emtricitabine combination therapy for the treatment of chronic Hepatitis B (HBV)


Condition Intervention Phase
Chronic Hepatitis B
 Drug: Tenofovir disoproxil fumarate
Drug: Emtricitabine
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Suppression of HBV DNA < 400 copies/mL [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hepatitis B e antigen (HBeAg) seroconversion [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
  • Development of resistance mutations [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
  • Hepatitis B surface antigen (HBsAg) loss [ Time Frame: Week 144 ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: August 2007
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tenofovir DF + Emtricitabine
Tenofovir DF + emtricitabine once daily
 Drug: Tenofovir disoproxil fumarate
Tenofovir disoproxil 300 mg oral tablet taken once daily
Other Name: Viread
Drug: Emtricitabine
emtricitabine 200 mg oral capsule taken once daily
Other Name: Emtriva
Experimental: Tenofovir DF
Tenofovir DF plus placebo to match emtricitabine taken once daily
 Drug: Tenofovir disoproxil fumarate
Tenofovir disoproxil 300 mg oral tablet taken once daily
Other Name: Viread
Drug: Placebo
Placebo to match emtricitabine taken once daily

Detailed Description:

The efficacy of tenofovir monotherapy versus tenofovir plus emtricitabine combination therapy will be evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes) and the development of any drug resistant mutations. The safety and tolerability of both tenofovir and tenofovir plus emtricitabine will also be evaluated by routine monitoring for adverse events and changes in laboratory parameters.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic HBV infection, defined as positive serum HBsAg for at least 6 months or HBsAg positive > 3 months and positive for immunoglobulin G (IgG) antibody against hepatitis B core antigen (anti-HBc)
  • 18 through 69 years of age, inclusive
  • HBeAg positive
  • HBV DNA >= 10^8 copies/mL
  • ALT <= the upper limit of the normal range (ULN)
  • Willing and able to provide written informed consent
  • Negative serum beta-human chorionic gonadotropin (HCG) (for females of childbearing potential only)
  • Calculated creatinine clearance >= 70 mL/min
  • Hemoglobin >=10 g/dL
  • Neutrophils >= 1,500 /mm3
  • No prior oral HBV therapy (e.g., nucleotide and/or nucleoside therapy or other investigational agents for HBV infection)

Exclusion Criteria:

  • 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 not willing to use an "effective" method of contraception during the study
  • Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 x ULN, prothrombin time (PT) >1.2 x ULN, platelets < 150,000/mm3, serum albumin < 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage)
  • Received interferon (pegylated or not) therapy within 6 months of the screening visit
  • alpha-fetoprotein > 50 ng/mL
  • Evidence of hepatocellular carcinoma (HCC)
  • Co infection with hepatitis C virus (HCV) (by serology), HIV, or hepatitis D virus (HDV)
  • Significant renal, cardiovascular, pulmonary, or neurological disease
  • Received solid organ or bone marrow transplantation
  • Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
  • Has proximal tubulopathy
  • Known hypersensitivity to the study drugs, the metabolites or formulation excipients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507507

  Show 45 Study Locations
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00507507     History of Changes
Other Study ID Numbers: GS-US-203-0101
Study First Received: July 25, 2007
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
tenofovir
monotherapy
emtricitabine
combination
hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
 Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 17, 2013