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Sponsored by: |
Hospices Civils de Lyon |
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Information provided by: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT00485342 |
The aim of this study is to compare two therapeutical strategies concerning the combination therapy (peginterferon alfa-2 and ribavirin) in naïve patients with chronic hepatitis C of genotype 1 or 4: “reference” strategy corresponding to standards of care recommended by the French consensus conference versus Test strategy which associate therapeutical drug monitoring of ribavirin with potential adaptation of ribavirin dosage and the co-prescription of epoetin beta in case of secondary anaemia.
Condition | Intervention | Phase |
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Chronic Hepatitis C |
Drug: ribavirin adjusted dose |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Pragmatic, Multicentric, Controlled and Randomised Clinical Trial Investigating in Open the Efficacy and Safety of Dose Adaptation of Ribavirin Using Therapeutic Drug Monitoring During Combination Peginterferon Alfa-2 and Ribavirin Treatment in Naive Patients With Chronic Hepatitis C of Genotype 1 or 4, and Presenting With a Slow Kinetics of Virological Response on a First Combination Therapy. |
Estimated Enrollment: | 198 |
Study Start Date: | April 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marianne Maynard, MD | 33 4 72 41 30 88 | marianne.maynard-muet@chu-lyon .fr |
France | |
Marianne Maynard | Recruiting |
Lyon, France, 69002 | |
Contact: Marianne Maynard, MD 33 4 72 41 30 88 marianne.maynard-muet@chu-lyon.fr | |
Principal Investigator: Christian Trépo, MD |
Principal Investigator: | Christian Trépo, MD | Hospices Civils de Lyon |
Study ID Numbers: | 2005-400 |
Study First Received: | June 8, 2007 |
Last Updated: | June 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00485342 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Chronic hepatitis C Genotype 1 or 4 Naïf bitherapy drug monitoring |
Antimetabolites Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Ribavirin Hepatitis, Viral, Human Hepatitis C Antiviral Agents Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents Liver Diseases RNA Virus Infections Hepatitis, Chronic Flaviviridae Infections Molecular Mechanisms of Pharmacological Action Ribavirin Hepatitis, Viral, Human |
Antiviral Agents Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Therapeutic Uses Hepatitis C Hepatitis C, Chronic |