Ribavirin Dose Optimization for the Treatment of Hepatitis C

Phase 2

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Peg-interferon alpha-2a, Ribavirin

• Registration Number: NCT01289496
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

Patients for whom treatment with peginterferon plus ribavirin was unsuccessful represent a category of patients for whom there is currently no worthwhile therapeutic alternative.

Several studies have shown that there is a relation between plasma ribavirin concentrations and treatment response. Adequate ribavirin plasma concentrations, especially during the first 12 weeks of treatment, should be associated with a better chance of response to the treatment.

The strategy for this study will be to use a loading dose of ribavirin before beginning the treatment with peg-interferon, thereby allowing for optimal ribavirin concentrations to be reached, and possibly improving the effectiveness of the treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-25
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Status Verified: 2012-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Age > 18 years
• Chronic hepatitis C and failure of prior treatment with peginterferon plus ribavirin (non-response: HCV-RNA decreased less than 2 logs after 3 months of treatment; relapse: HCV-RNA that becomes positive again after treatment is stopped
• Compensated hepatic disease (Child-Pugh ≤ 6)
• Provision by patient of his or her written consent

Exclusion Criteria

• Females who are pregnant or lactating will be excluded
• Renal failure (estimated glomerular filtration rate < 50 ml/min)
• A contraindication to treatment with peginterferon plus ribavirin (uncontrolled psychiatric illness, pregnancy/nursing/non-use of effective contraceptive method, uncontrolled epilepsy for at least 6 months, heart failure, unstable angina, hemoglobin < 120 g/L, neutrophils < 1,000/mm3, platelets < 50 x 109/L, or any other condition that, in the investigator's opinion, contraindicates use of the treatment)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peg-interferon alpha-2a, Ribavirin	Peg-interferon alpha-2a, Ribavirin	Adult patients with chronic hepatitis C and failure of prior treatment with peginterferon plus ribavirin(non-response or relapse). This is a pilot study with no control group.

Primary Outcome Measures

Name	Time	Method
Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay	up to 24 weeks post treatment	Qualitative

Secondary Outcome Measures

Name	Time	Method
Viral Kinetics	up to 24 weeks post treatment	Plasma Ribavirin (RBV) Assays; Immune Response
Neutrophils	up to 24-48 weeks of treatment	If neutrophils are \< 500/mm, neupogen may be added
Hemoglobin	up to 24-48 weeks of treatment	If hemoglobin is \< 100g/L, erythropoietin and/or transfusions may be prescribed

Trial Locations

Locations (1)

Centre hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada