A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Hepatitis B

In brief

This 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 pre-core mutant 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

NCT00117676

Run by

Gilead Sciences

People needed

382

Starts

2005-02-01

Expected to finish

2016-01-01

Last updated by the study team

2017-03-07

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 Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — San Jose, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Boston, Massachusetts, 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 — Falls Church, Virginia, United States
• Study site — Richmond, Virginia, 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 — Fitzroy, Victoria, Australia
• Study site — Heidelberg, Victoria, Australia
• Study site — Prahan, Victoria, Australia
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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