Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy
Phase 4
Withdrawn
- Conditions
- Chronic Hepatitis B
- Interventions
- Registration Number
- NCT00409019
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B
- Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening.
Other inclusion criteria may apply.
Exclusion Criteria
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis C, hepatitis D or HIV
- Patient previously received nucleoside(tide) therapy other than adefovir
- Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months
Other exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Adefovir Study cancelled: Withdrawn before enrollment of any participants 1 Telbivudine Study cancelled: Withdrawn before enrollment of any participants 3 Tenofovir Study cancelled: Withdrawn before enrollment of any participants
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method