NCT01097395

Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Virus

Interventions

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

Timeline

• Start date: 2010-02-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2010-04-01
• Last updated: 2021-09-16
• Results posted: 2021-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study