Ribavirin Dose Optimization for the Treatment of Hepatitis C

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Peg-interferon alpha-2a, Ribavirin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01289496

Control Number: 143155 (Other Identifier)

ML25553

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Peg-interferon alpha-2a, Ribavirin

Experimental group

Description:

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.

Treatment:

Drug: Peg-interferon alpha-2a, Ribavirin