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Sponsored by: |
Foundation for Liver Research |
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Information provided by: | Foundation for Liver Research |
ClinicalTrials.gov Identifier: | NCT00363259 |
The purpose of this study is to compare the sustained virological response rate at 24 weeks after the end of experimental treatment (induction and 72 weeks) to that of standard 48 weeks treatment with PEG-inteferon alfa-2b and ribavirin in patients with chronic hepatitis C previous unresponsive to interferon alfa monotherapy or interferon alfa/ribavirin combination therapy.
Condition | Intervention | Phase |
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Hepatitis C |
Drug: Peginterferon alfa-2b Drug: Ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pegintron Induction Therapy in Previous Non-Responders With Chronic HCV: A Dutch Multicenter Randomized Controlled Trial. (PIT-Study) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Erasmus MC | |
Rotterdam, Netherlands, 3000 CA | |
OLVG | |
Amsterdam, Netherlands, 1091HA | |
Atrium Medisch Centrum | |
Heerlen, Netherlands, 6401 CX | |
Ziekenhuis Zeeuws Vlaanderen | |
Terneuzen, Netherlands, 4535 PA | |
LUMC | |
Leiden, Netherlands, 2300 RC | |
Rijnstate Ziekenhuis | |
Arnhem, Netherlands, 6815 AN | |
UMC | |
Utrecht, Netherlands, 3584 CX |
Principal Investigator: | Rob J de Knegt, MD, PhD | Erasmus Medical Center |
Study ID Numbers: | HCV01-01 |
Study First Received: | August 10, 2006 |
Last Updated: | August 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00363259 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Virus Diseases Hepatitis Anti-Infective Agents Liver Diseases Digestive System Diseases |
Ribavirin Peginterferon alfa-2b Hepatitis, Viral, Human Hepatitis C Antiviral Agents |
Anti-Infective Agents Liver Diseases RNA Virus Infections Flaviviridae Infections Hepatitis, Viral, Human Antiviral Agents Pharmacologic Actions |
Hepatitis Virus Diseases Digestive System Diseases Therapeutic Uses Peginterferon alfa-2b Hepatitis C |