NCT00115245CompletedPhase 3
A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis
- Locations
- 15
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Study Sites (15)
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