Conditions: Chronic Hepatitis B
Keywords: Hepatitis B Hepatitis Tenofovir disoproxil fumarate Tenofovir DF Asian-American
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 90
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the antiviral activity and safety of tenofovir disoproxil fumarate (TDF) in Asian-American adults (self-reported Asian descent, living in the United States) with chronic hepatitis B infection. All participants will receive active treatment with TDF for 48 weeks.

Detailed description:
Efficacy of TDF will be evaluated for reductions in serum HBV DNA, changes in liver enzymes, and the generation of antibody to the virus. Safety will be assessed by evaluating adverse events, laboratory abnormalities, and the development of drug resistance mutations.

Arms:
arm 1: 300-mg tablet (marketed formulation) taken orally once daily

Interventions: intervention 1: Tenofovir disoproxil fumarate
Intervention descriptions: intervention 1: 300-mg tablet (marketed formulation) taken orally once daily

Protocol document: