A Single-arm Study Evaluating the Efficacy and Safety of Telbivudine With or Without add-on Tenofovir in Adults With HBeAg-positive Chronic Hepatitis B (CHB)

Phase 4

Completed

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

• Registration Number: NCT00651209
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate the use of telbivudine for patients with HBeAg-positive CHB with an option to intensify treatment at Week 24 by adding tenofovir for patients who do not achieve HBV DNA non-detectability.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-04-02
• Primary Completion: 2011-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Tenofovir	Sub-group 1- continue telbivudine if HBV DNA non-detectable at week 24 Sub-group 2- tenofovir added to telbivudine in patients if HBV DNA detectable at week 24

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to determine if telbivudine early non-responders can achieve an antiviral response with the addition of tenofovir.	at week 52

Secondary Outcome Measures

Name	Time	Method
To estimate the rate of virologic breakthrough up to week 48 and week 104 To assess the rate of treatment-emergent genotypically confirmed HBV resistance associated with viral breakthrough up to weeks 48 and 104 and 104	at week 52 and 104

Trial Locations

Locations (1)

Novartis; 🇹🇭 Bangkok, Thailand