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A 96 Week Study to Compare Tenofovir Versus Tenofovir Plus Emtricitabine for the Treatment of Chronic Hepatitis B
This study is ongoing, but not recruiting participants.
Sponsored by: Gilead Sciences
Information provided by: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00507507
  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


Condition Intervention Phase
Chronic Hepatitis B
Drug: tenofovir disoproxil fumarate
Drug: tenofovir disoproxil plus emtricitabine
Phase II

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Hepatitis B Vaccines Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Suppression of HBV DNA < 169 copies/mL [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Suppression of HBV DNA < 169 copies/mL [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Tenofovir DF 300 mg + Emtricitabine 200 mg
Drug: tenofovir disoproxil plus emtricitabine
tenofovir disoproxil 300 mg oral tablet once daily plus emtricitabine 200 mg oral capsule once daily
B: Experimental
Tenofovir DF
Drug: tenofovir disoproxil fumarate
tenofovir disoproxil 300 mg oral tablet once daily plus matching emtricitabine placebo

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 IgG anti-HBc
  • 18 through 69 years of age, inclusive
  • HBeAg positive
  • HBV DNA >= 10^8 copies/mL
  • ALT <= ULN
  • Willing and able to provide written informed consent
  • Negative serum beta-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, 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 HCV (by serology), HIV, or 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

Responsible Party: Gilead Sciences ( David Oldach, MD/Director Clinical Research )
Study ID Numbers: GS-US-203-0101
Study First Received: July 25, 2007
Last Updated: August 21, 2008
ClinicalTrials.gov Identifier: NCT00507507  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Emtricitabine
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis B
Tenofovir
Hepatitis, Viral, Human
DNA Virus Infections
Tenofovir disoproxil

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009