RIBAJUSTE Clinical Trial Investigating the Efficacy and Safety of Dose Adaptation of Ribavirin (RIBAJUSTE)
|ClinicalTrials.gov Identifier: NCT00485342|
Recruitment Status : Unknown
Verified January 2012 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : June 12, 2007
Last Update Posted : January 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Peg-interferon alpha 2a and ribavin Drug: ribavirin with adaptation dose||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||236 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentric, Controlled and Randomised Open Clinical Trial Investigating the Efficacy and Safety of Dose Adaptation of Ribavirin Using Pharmacologic Measures of Ribavirin Exposition During Combination Peginterferon Alfa-2 and Ribavirin Treatment in Naive Patients With Chronic Hepatitis C of Genotype 1 on a First Combination Therapy|
|Study Start Date :||April 2006|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||March 2013|
No Intervention: standard dose
the "reference" strategy : Peg-interferon alpha 2a (180 µg/week) and ribavine (1000 mg/day if weight < 75 kg and 1200 mg/day if weight ≥ 75 kg)
Drug: Peg-interferon alpha 2a and ribavin
Date of ribavirin AUC : Day 0 (beginning of treatment) Bitherapy : Peg-interferon alpha 2a (180 µg/week) with ribavirin (1000 mg/day if weight < 75 kg and 1200 mg/day if weight ≥ 75 kg).
Duration of treatment : 48 weeks Duration of study for patients : 72 weeks
Experimental: adjusted dose
individual dose adjustment of ribavirin dose at D7, based on ribavirin abbreviated AUC-0-4H , estimated itself by two independent methods: multiple linear regression and bayesien estimation based on three ribavirin concentration measurements obtained at 0.5H, 1H, 2H after the first intake of 600 mg at D0.
Drug: ribavirin with adaptation dose
Date of ribavirin AUC : Day 0 (beginning of treatment) Bitherapy : Peg-interferon alpha 2a (180 µg/week) with ribavirin (dose adaptation) Dose adaptation : Day 7, dependant of result of AUC Ribavirin dose increments : 200 mg, 400 mg or 600 mg with a maximum of 50% of the initial dose (600 mg) applied every 4 days up to the adjusted dose proposed in order to reach the targeted AUC.
The maximum daily dose will not exceed 3600 mg Duration of treatment : 48 weeks Duration of study for patients : 72 weeks
- Inter-group comparison of sustained virological response rates as defined by the proportion of subjects with a negative PCR HCV-RNA test at Week 72 [ Time Frame: 72 weeks ]
- Efficacy endpoints [ Time Frame: 72 weeks ]To compare the virological response rate between the two groups: Rapid Virological Response (RVR) at W4, Early Virological Response (EVR) at W12, Virological Response at W24, and End-Of-Treatment response (EOT) at W48 ; To determine the relapse rate (between W48 and W72) and to determine the proportion of patients reaching the target trough ribavirin concentration of 2 mg/L at W4 or W8 after ribavirin dose adjustment in the first 7 days of treatment.
- safety endpoints [ Time Frame: 72 weeks ]To investigate the clinical and biological tolerability in patients with dose-adjusted ribavirin compared to those with standard ribavirin doses, the proportion of patients needing EPO co-prescription due to secondary anemia in each group, to estimate the rate of treatment discontinuation due to serious or other relevant adverse events in each group and to determine the proportion of subjects reaching ribavirin trough plasma concentrations considered as "toxic" (> 3.5 mg/L) at W4 and W8, in each arm.
- Economic endpoints [ Time Frame: 72 weeks ]Comparaison of the "test" and "standard" strategies by a medico-economic analysis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485342
|Contact: Marianne Maynard, MD||33 4 72 41 30 firstname.lastname@example.org|
|Contact: Véronique LOUSTAUD-RATTI, MD||33 5 55 05 66 email@example.com|
|Lyon, France, 69002|
|Contact: Marianne Maynard, MD 33 4 72 41 30 88 firstname.lastname@example.org|
|Principal Investigator: Christian Trépo, MD|
|Principal Investigator:||Christian Trépo, MD||Hospices Civils de Lyon|