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Sponsors and Collaborators: |
Hopital A Michallon University Hospital, Grenoble Central Hospital, Nancy, France |
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Information provided by: | Hopital A Michallon |
ClinicalTrials.gov Identifier: | NCT00209755 |
Investigation of the usefullness of therapeutical drug monitoring of ribavirin for dose adaptation during combination therapy of chronic hepatitis C patients.
The correlation between ribavirin plasma concentration levels at week 4 (steady state) and early virological response (HCV-RNA decay from baseline to week 12) is to be tested in 40 patients approximately.
Condition | Intervention |
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Chronic Hepatitis C |
Procedure: therapeutic drug monitoring of ribavirin and dose adaptation |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Diagnostic Value of Plasma Ribavirin Assay During the Combination Therapy « Pegylated Interferon + Ribavirin » in Chronic Hepatitis C. |
Estimated Enrollment: | 40 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | July 2004 |
Background and rational The serum concentrationS of ribavirin commonly range from 1 to 5 in patients during the combination treatment « interferon+ribavirin » (Larrat et al. 2003). However, the bioavailibility of ribavirin is not considered in the current recommendation for this treatment.
The aim of this study is to demonstrate that the adaptation « à la carte » of ribavirin posology according to its serum concentration could improve the efficacy and the tolerance of the hepatitis C combination therapy.
Study design This study is a prospective clinical pharmacology trial in patients on combination treatment for a chronic hepatitis C with genotype 1 or 4 virus.
The evaluation will concern the serum ribavirin concentration during the first three months of treatment and its correlation with the evolution of hemoglobin (toxicity marker) or viral load (efficacy marker).
After the 3 months of the study, a adaptation of posology based on serum ribavirin level will be offer to the patients for the rest of the treatment period. A control of the ribavirin level one month after the dose adaptation will be performed.
Judgement endpoints
There will be intermediate endpoints :
The primary judgement endpoint will be the statistical correlation as following :
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
university hospital ; HGE dpt | |
Grenoble, France, 38043 |
Principal Investigator: | Jean Pierre ZARSKI, MD | university hospital of Grenoble (France) |
Study ID Numbers: | ribatop - afssaps #031161, N.A. |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00209755 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
chronic hepatitis C |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Interferons Ribavirin Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action |
Flaviviridae Infections Therapeutic Uses Antiviral Agents Pharmacologic Actions |