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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 |
---|---|
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.
United States, Arizona | |
Phoenix, Arizona, United States | |
United States, California | |
Los Angeles, California, United States | |
United States, Colorado | |
Denver, Colorado, United States | |
United States, Indiana | |
Indianapolis, Indiana, United States | |
United States, Minnesota | |
Rochester, Minnesota, United States | |
United States, New York | |
New York, New York, United States | |
United States, Texas | |
Houston, Texas, United States | |
United States, Wisconsin | |
Madison, Wisconsin, United States | |
Australia | |
Heidelburg, Australia | |
Canada | |
Winnipeg, Canada | |
China | |
Hong Kong, China | |
France | |
Villejuif Cedex, France | |
Germany | |
Hannover, Germany | |
India | |
Novartis | |
New Delhi, India | |
Israel | |
Tel Aviv, Israel | |
Korea, Republic of | |
Seoul, Korea, Republic of | |
Latvia | |
Novartis | |
Riga, Latvia | |
Malaysia | |
Novartis | |
Kuala Lumpur, Malaysia | |
New Zealand | |
Auckland, New Zealand | |
Poland | |
Novartis | |
Krakow, Poland | |
Russian Federation | |
Novartis | |
Moscow, Russian Federation | |
Singapore | |
Singapore, Singapore | |
Spain | |
Barcelona, Spain | |
Taiwan | |
Taipei, Taiwan | |
Thailand | |
Bangkok, Thailand | |
Turkey | |
Novartis | |
Istanbul, Turkey | |
United Kingdom | |
London, United Kingdom | |
Vietnam | |
Novartis | |
Hanoi, Vietnam |
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 |