drugset / Trial / NCT00804622

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

NCT00804622

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-12
Primary completion
2009-06
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Telbivudine Small molecule 600 mg Oral
Comparator tenofovir disproxil fumarate Unknown 300 mg Oral