Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
Phase 3
Completed
- Conditions
- Chronic Hepatitis B
- Registration Number
- NCT00115245
- Lead Sponsor
- Novartis
- Brief Summary
This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B
- Detectable serum HBsAg at the Screening visit
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Patient is pregnant or breastfeeding.
- Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
- Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time
- Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study
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