A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B
Completed · Phase 3
Conditions studied: Chronic Hepatitis B
In brief
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.
Key facts
- Study ID
- NCT00057265
- Run by
- Novartis
- Starts
- 2003-02-01
- Last updated by the study team
- 2015-03-20
Who can join
Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV
- Other protocol-defined inclusion criteria may apply.
You may not qualify if…
- 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.
Where it is running
- Study site — Los Angeles, California, United States
- Study site — Orange, California, United States
- Study site — San Diego, California, United States
- Study site — Hackensack, New Jersey, United States
- Study site — Houston, Texas, United States
- Study site — Seoul, South Korea
- Study site — Barcelona, Spain
- Study site — Valencia, Spain
- Study site — Bangkok, Thailand
- Study site — Istanbul, Turkey (Türkiye)
- Study site — London, United Kingdom
Full record on ClinicalTrials.gov
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