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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00412750 |
To evaluate the combination of telbivudine and peginterferon alpha-2a for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.
Condition | Intervention | Phase |
---|---|---|
Hepatitis B |
Drug: Telbivudine, peginterferon alpha-2a |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label, Controlled, Multi-Center Two-Year Study Comparing Efficacy and Safety of Telbivudine, 600 mg PO in Combination With Peginterferon Alpha-2a sq180 µg With Peginterferon Alpha-2a Monotherapy, and With Telbivudine Monotherapy in Treatment naïve Patients With HBeAg-Positive CHB |
Estimated Enrollment: | 300 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2009 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documented Chronic hepatitis B (CHB) defined by all of the following:
Exclusion Criteria:
Has any of the following drug therapy:
Patient has any of the following:
Responsible Party: | novatis ( novartis ) |
Study ID Numbers: | CLDT600A2406 |
Study First Received: | December 15, 2006 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00412750 |
Health Authority: | United States: Food and Drug Administration; Australia: Therapeutic Goods Administration; Belgium: Pharmaceutical Inspectorate; France: Sanitary Safety of Health Products Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Netherlands: Medicines Evaluation Board; Spain: Ministry of Health and Consumption; Switzerland: Agency for Therapeutic Products; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Israel: Ministry of Health; Argentina: National Administration of Drugs, Foods and Medical Technology; Taiwan: National Laboratories of Foods and Drugs; Singapore: Health Sciences Authority; New Zealand: Medicines and Medical Devices Safety Authority; Hong Kong: Department of Health |
hepatitis B HBV chronic hepatitis B telbivudine peginterferon |
Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Hepatitis, Viral, Human Hepatitis Virus Diseases |
Digestive System Diseases Hepatitis B, Chronic Hepatitis B Peginterferon alfa-2a DNA Virus Infections Interferon Alfa-2a |
Anti-Infective Agents Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs Growth Inhibitors |
Angiogenesis Modulating Agents Angiogenesis Inhibitors Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions |