A 96 Week Study to Compare Tenofovir Versus Tenofovir Plus Emtricitabine for the Treatment of Chronic Hepatitis B
Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: tenofovir disoproxil fumarate (Drug); tenofovir disoproxil plus emtricitabine (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Gilead Sciences
Summary
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
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Suppression of HBV DNA < 169 copies/mL
Secondary outcome: Suppression of HBV DNA < 169 copies/mL
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
Minimum age: 18 Years.
Maximum age: 69 Years.
Gender(s): Both.
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.
Locations and Contacts
Strasbourg 67091, France
Lille 59037, France
Lyon 69288, France
Duesseldorf 40237, Germany
Hamburg 20251, Germany
Hannover 30623, Germany
Berlin 10969, Germany
Berlin 13353, Germany
Frankfurt 60590, Germany
Herne 44623, Germany
Heidelberg 69120, Germany
Mainz 55131, Germany
Shatin, Hong Kong
Tai Po, Hong Kong
Pokfulam, Hong Kong
Hamilton, New Zealand
Bydgoszcz 85-030, Poland
Chorzow 41-500, Poland
Warszawa 01-201, Poland
Singapore 529889, Singapore
Singapore 119074, Singapore
Kaoshiung 833, Taiwan
Taipei, Taiwan
Kaohsiung 807, Taiwan
Tainan 107, Taiwan
London NW3 2QG, United Kingdom
Sheffield S10 2JF, United Kingdom
Calgary, Alberta T2N4N1, Canada
Grafton, Auckland 1150, New Zealand
Vancouver, British Columbia V5Z1H2, Canada
San Francisco, California 11355, United States
San Diego, California 92115, United States
Los Angeles, California 90048, United States
Miami, Florida 33136, United States
Detroit, Michigan 48202, United States
Westmead, New South Wales 2145, Australia
Camperdown, New South Wales 2050, Australia
New York, New York 10029-6574, United States
Manhasset, New York 11030, United States
New York, New York 10021, United States
Toronto, Ontario M5G 2C4, Canada
Germantown, Tennessee 38138, United States
Melbourne, Victoria 3004, Australia
Heidelburg, Victoria 3081, Australia
Seattle, Washington 98111, United States
Additional Information
Starting date: August 2007
Ending date: April 2010
Last updated: May 28, 2008
|
