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Sponsors and Collaborators: |
Universitätsklinikum Hamburg-Eppendorf Dr. med Peter Buggisch - University hospital Eppendorf Hoffmann-La Roche |
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Information provided by: | Universitätsklinikum Hamburg-Eppendorf |
ClinicalTrials.gov Identifier: | NCT00299923 |
The aim of this study is, to compare the relapse rate in chronic HCV patients with genotype 1 or 3 under the combination of standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a), Ribavirin (RBV) and Amantadine (AMA) given for 72 weeks (group A), versus the same combination, given for 48 weeks (group B) in patients who relapsed to previous combination therapy to conventional or pegylated (PEG) Interferon alfa and Ribavirin. Relapse ist defined as percentage of patients with non-detectable HCV-RNA at end of therapy (week 48 GT1/ week 24 GT 3) who become HCV-RNA positive during a follow-up period of 24 weeks.
Condition | Intervention | Phase |
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Hepatitis C, Chronic Relapse |
Drug: Peginterferon alfa-2a, Ribavirin, Amantadine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Open-Label, Multicenter Study Examining the Effects of Duration of Treatment of PEGASYS® in Combination With Daily COPEGUS® + Amantadine in Patients With Chronic HCV After Relapse to Previous (Peg)IFN + Ribavirin Therapy. |
Estimated Enrollment: | 300 |
Study Start Date: | November 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria (at screening):
Principal Investigator: | Peter Buggisch, Dr. | Universitätsklinikum Hamburg-Eppendorf, Medizinische Klinik 1 |
Study ID Numbers: | ML 18545 (TRELA), EudraCT-Nr.: 2005-001207-19 |
Study First Received: | March 6, 2006 |
Last Updated: | March 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00299923 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
drug therapy Interferon |
Liver Diseases Hepatitis, Chronic Ribavirin Interferons Hepatitis, Viral, Human Recurrence Hepatitis |
Virus Diseases Dopamine Digestive System Diseases Peginterferon alfa-2a Hepatitis C Amantadine Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents RNA Virus Infections Disease Attributes Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Anti-Dyskinesia Agents Physiological Effects of Drugs Antiparkinson Agents |
Antiviral Agents Pharmacologic Actions Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Analgesics Central Nervous System Agents |