Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B

Phase 4

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Telbivudine

• Registration Number: NCT00646503
• Lead Sponsor: Novartis

Brief Summary

This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Telbivudine	600 mg/day, oral telbivudine for 52 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of patients experiencing serious adverse events (for all SAEs, and SAEs attributed to study drug). Proportion of patients experiencing adverse events, coded by body system ( all AEs, and AEs attributed to study drug).	At Baseline, Week 24 and Week 52

Secondary Outcome Measures

Name	Time	Method
For HBeAg-positive patients, Maintained Virologic Response, here defined as HBeAg loss and serum HBV DNA PCR negative (COBAS Amplicor PCR < 300 copies/ml) during the whole study period.	At Baseline, Week 24 and Week 52

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Beijing, China