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Therapeutic Areas: Gastroenterology | Immunology/Infectious Diseases
Disease Category: Hepatitis
Trial Information
A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF versus Adefovir Dipivoxil for the Treatment of Presumed Pre-core Mutant Chronic Hepatitis B [GS-US-174-0102]
This is a research study involving an experimental drug named
tenofovir DF for the treatment of the chronic hepatitis B virus
(HBV). The purpose of this study is to compare the safety and the
effectiveness of tenofovir DF (TDF) to that of adefovir dipivoxil
(ADV) in patients chronically infected with HBV who have never
taken an oral treatment for their HBV. Participants will take TDF +
placebo or ADV + placebo.
Participation will last about 48 weeks and there will be about 14
clinic visits.
All study procedures and medications are provided at no cost to
you.
Compensation Provided
Patient Inclusion/Exclusion Criteria:
You may be eligible to participate if you
-are 18-69 years old
-have been diagnosed with chronic HBV infection for at least 6
months
You will not be able to participate if you
-are pregnant or breastfeeding
-are coinfected with HIV, HCV or HDV
-have taken an oral treatment for your HBV
-have received an organ or bone marrow transplant
Alison Uriel, MD
Mount Sinai Medical Center
One Gustave L. Levy Place
New York, NY 10029
Phone: 212-241-8903
Fax: 212-241-4465
EMail: alison.uriel@mountsinai.org
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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