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

Chronic Hepatitis B Clinical Trial

Official title:
A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of Presumed Pre-Core Mutant Chronic Hepatitis B

Clinical Trial Summary

This study is designed to evaluate the safety and antiviral activity of tenofovir disoproxil fumarate (TDF) compared to adefovir dipivoxil (ADV) for 48 weeks for the treatment of HBeAg-negative chronic hepatitis B. Subjects will either receive TDF or the approved hepatitis B therapy ADV. After 48 weeks all subjects will be switched to open-label TDF.

Clinical Trial Description

The efficacy of TDF versus ADV will be evaluated for histologic improvement, reductions in serum hepatitis B virus deoxyribonucleic acid (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-resistant mutations. After 48 weeks all subjects will receive open-label TDF, and the efficacy and safety of TDF will continue to be monitored for the remainder of the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00117676
Study type Interventional
Source Gilead Sciences
Contact
Status Completed
Phase Phase 3
Start date February 2005
Completion date January 2016
View Details
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