Overview

Effects of Telbivudine and Tenofovir Disproxil Fumarate on the Kinetics of Hepatitis B Virus DNA in Chronic Hepatitis B (CHB)

Status:
Completed

Trial end date:
2010-03-01

Target enrollment:

Participant gender:

Summary

The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg once daily (QD) taken together versus tenofovir DF 300 mg once daily (QD) or versus telbivudine 600 mg monotherapy daily (QD). This is an open-labeled, active controlled, viral kinetics study which means the subjects and study doctor will know what study drug subjects have been assigned. This study is open to male and female subjects, <40 years of age, who have been infected with HBV for at least 6 months and have not received oral treatment for HBV.

Phase:

Phase 2

Details

Lead Sponsor:

The University of Hong Kong

Collaborator:

Novartis Pharmaceuticals

Treatments:

Telbivudine
Tenofovir