An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
Phase 2
Completed
- Conditions
- Hepatitis B
- Registration Number
- NCT00124241
- Lead Sponsor
- Novartis
- Brief Summary
This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patient has completed protocol NV-02B-003 without a serious adverse event attributed to study drug
- Patient remains seropositive for hepatitis B surface antigen (HBsAg)
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Patient is pregnant or breast-feeding
- Patient has signs of decompensated chronic hepatitis B
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method