CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 35 enrolled
Drug / intervention
ribavirindrug
Likely dose
ribavirin 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01097395
NCT01097395Phase 4Completed
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Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection

University of Colorado, Denver·interventional·Posted Apr 1, 2010·Updated Sep 16, 2021

In Brief

A Phase 4 clinical trial evaluating ribavirin for Hepatitis C Virus. Completed, enrolled 35 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if concentration-controlled ribavirin dosing can achieve a targeted level of plasma exposures and if it appears safe and effective compared with standard weight-based ribavirin dosing. Forty, previously treatment-naive participants with genotype 1 disease will be randomized to receive concentration-guided or standard weight-based ribavirin. Peginterferon alfa 2a,ribavirin, and telaprevir will be provided through the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 1, 2010
Enrollment StartFeb 1, 2010
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 16.3 years ago

Interventions

ribavirindrug

Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12