A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B
Status and phase
Completed
Phase 3
Conditions
Chronic Hepatitis B
Treatments
Drug: telbivudine or lamivudine
Details and patient eligibility
About
This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking Lamivudine.
Sex
All
Ages
16 to 70 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV
Other protocol-defined inclusion criteria may apply.
Exclusion criteria
- Patient is pregnant or breastfeeding
- Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-2.
- Patient previously received lamivudine or an investigational anti-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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
11
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Data sourced from clinicaltrials.gov
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