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)
- 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
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