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Sponsors and Collaborators: |
Idenix Pharmaceuticals Novartis |
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Information provided by: | Idenix Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00057265 |
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.
Condition | Intervention | Phase |
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Chronic Hepatitis B |
Drug: telbivudine or lamivudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B |
Study Start Date: | February 2003 |
Ages Eligible for Study: | 16 Years to 70 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Other protocol defined exclusion criteria may apply.
United States, California | |
San Diego, California, United States | |
Los Angeles, California, United States | |
Orange, California, United States | |
United States, New Jersey | |
Hackensack, New Jersey, United States | |
United States, Texas | |
Houston, Texas, United States | |
Korea, Republic of | |
Seoul, Korea, Republic of | |
Spain | |
Barcelona, Spain | |
Valencia, Spain | |
Thailand | |
Bangkok, Thailand | |
Turkey | |
Istanbul, Turkey | |
United Kingdom | |
London, United Kingdom |
Study ID Numbers: | NV-02B-007 |
Study First Received: | March 28, 2003 |
Last Updated: | November 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00057265 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis B, Chronic Hepatitis B Lamivudine Hepatitis, Viral, Human DNA Virus Infections |
Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Reverse Transcriptase Inhibitors |