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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00076336 |
This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus 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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Hepatitis Hepatitis B, Chronic Cirrhosis |
Drug: telbivudine Drug: lamivudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis |
Enrollment: | 232 |
Study Start Date: | December 2003 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: telbivudine
600mg/day oral tablet for 2 years
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2: Active Comparator |
Drug: lamivudine
100mg/day oral tablet for 2 years
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Ages Eligible for Study: | 16 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
Responsible Party: | ( Novartis ) |
Study ID Numbers: | CLDT600A2301 |
Study First Received: | January 20, 2004 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00076336 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Liver Diseases Anti-HIV Agents Hepatitis, Chronic Fibrosis Hepatitis, Viral, Human Lamivudine Liver Cirrhosis Antiviral Agents |
Reverse Transcriptase Inhibitors Hepatitis Virus Diseases Digestive System Diseases Anti-Retroviral Agents Hepatitis B, Chronic Hepatitis B DNA Virus Infections |
Anti-Infective Agents Liver Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Fibrosis Lamivudine Hepatitis, Viral, Human Enzyme Inhibitors Liver Cirrhosis Antiviral Agents Hepadnaviridae Infections |
Pharmacologic Actions Reverse Transcriptase Inhibitors Hepatitis Virus Diseases Digestive System Diseases Pathologic Processes Anti-Retroviral Agents Therapeutic Uses Hepatitis B, Chronic Hepatitis B DNA Virus Infections Nucleic Acid Synthesis Inhibitors |