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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 ALT
This study is ongoing, but not recruiting participants.
First Received: July 25, 2007   Last Updated: February 27, 2009   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


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:
  • HBeAg seroconversion [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
  • Development of resistance mutations [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
  • HBsAg loss [ Time Frame: Week 144 ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: August 2007
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (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

  Hide Study Locations
Locations
United States, California
San Francisco, California, United States, 11355
San Diego, California, United States, 92115
Los Angeles, California, United States, 90048
United States, Florida
Miami, Florida, United States, 33136
United States, Michigan
Detroit, Michigan, United States, 48202
United States, New York
New York, New York, United States, 10029-6574
Manhasset, New York, United States, 11030
New York, New York, United States, 10021
United States, Tennessee
Germantown, Tennessee, United States, 38138
United States, Washington
Seattle, Washington, United States, 98111
Australia, New South Wales
Westmead, New South Wales, Australia, 2145
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Melbourne, Victoria, Australia, 3004
Heidelburg, Victoria, Australia, 3081
Canada, Alberta
Calgary, Alberta, Canada, T2N4N1
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z1H2
Canada, Ontario
Toronto, Ontario, Canada, M5G 2C4
France
Strasbourg, France, 67091
Lille, France, 59037
Lyon, France, 69288
Germany
Duesseldorf, Germany, 40237
Hamburg, Germany, 20251
Hannover, Germany, 30623
Berlin, Germany, 10969
Berlin, Germany, 13353
Frankfurt, Germany, 60590
Herne, Germany, 44623
Heidelberg, Germany, 69120
Mainz, Germany, 55131
Hong Kong
Shatin, Hong Kong
Tai Po, Hong Kong
Pokfulam, Hong Kong
New Zealand
Hamilton, New Zealand
New Zealand, Auckland
Grafton, Auckland, New Zealand, 1150
Poland
Bydgoszcz, Poland, 85-030
Chorzow, Poland, 41-500
Warszawa, Poland, 01-201
Singapore
Singapore, Singapore, 529889
Singapore, Singapore, 119074
Taiwan
Kaoshiung, Taiwan, 833
Taipei, Taiwan
Kaohsiung, Taiwan, 807
Tainan, Taiwan, 107
United Kingdom
London, United Kingdom, NW3 2QG
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

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: February 27, 2009
ClinicalTrials.gov Identifier: NCT00507507     History of Changes
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anti-Infective Agents
Liver Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Hepatitis, Chronic
Hepatitis, Viral, Human
Enzyme Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Hepatitis
Virus Diseases
Digestive System Diseases
Anti-Retroviral Agents
Emtricitabine
Therapeutic Uses
Hepatitis B, Chronic
Hepatitis B
Tenofovir
DNA Virus Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

ClinicalTrials.gov processed this record on November 27, 2009