A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Hepatitis B
In brief
The primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of HBeAg-positive chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.
Key facts
- Study ID
- NCT00116805
- Run by
- Gilead Sciences
- People needed
- 266
- Starts
- 2005-06-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-03-09
Who can join
Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Study site — Pasadena, California, United States
- Study site — San Diego, California, United States
- Study site — San Jose, California, United States
- Study site — Miami, Florida, United States
- Study site — Atlanta, Georgia, United States
- Study site — Atlanta, Georgia, United States
- Study site — Honolulu, Hawaii, United States
- Study site — Baltimore, Maryland, United States
- Study site — Ann Arbor, Michigan, United States
- Study site — Detroit, Michigan, United States
- Study site — St Louis, Missouri, United States
- Study site — Flushing, New York, United States
- Study site — New York, New York, United States
- Study site — New York, New York, United States
- Study site — New York, New York, United States
- Study site — Fairfax, Virginia, United States
- Study site — Falls Church, Virginia, United States
- Study site — Richmond, Virginia, United States
- Study site — Seattle, Washington, United States
- Study site — Camperdown, New South Wales, Australia
- Study site — Concord, New South Wales, Australia
- Study site — Westmead, New South Wales, Australia
- Study site — Woolloongabba, Queensland, Australia
- Study site — Clayton, Victoria, Australia
- Study site — Orange, California, United States
Full record on ClinicalTrials.gov
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