drugset / Trial / NCT00781105

Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

NCT00781105

Phase 4 Completed 2200 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.

Timeline

Start
2008-08-01
Primary completion
2010-09-16
Completion
2010-09-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Telbivudine Small molecule 600 mg Oral