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Sponsored by: |
Foundation for Liver Research |
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Information provided by: | Foundation for Liver Research |
ClinicalTrials.gov Identifier: | NCT00381953 |
The purpose of this study is to compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCVRNA suppression of 360 mug peginterferon QW, 9 MU interferon daily or 4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment. Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.
Condition | Intervention | Phase |
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Hepatitis C |
Drug: Peginterferon alfa-2a Drug: Interferon alfa-2a Drug: Ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Comparative Study of High-Dose Interferon Alfa-2a and Pegylated Interferon Alfa-2a for Induction Therapy in Difficult to Treat Genotype 1 Patients With Chronic HCV |
Enrollment: | 33 |
Study Start Date: | February 2003 |
Study Completion Date: | July 2006 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | HCV02-01 |
Study First Received: | September 27, 2006 |
Last Updated: | July 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00381953 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Interferon-alpha Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Interferons |
Ribavirin Peginterferon alfa-2a Hepatitis, Viral, Human Hepatitis C Interferon Alfa-2a |
Anti-Infective Agents RNA Virus Infections Flaviviridae Infections Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |