Ribavirin Dose Optimization for the Treatment of Hepatitis C
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study|
- Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay [ Time Frame: up to 24 weeks post treatment ] [ Designated as safety issue: No ]Qualitative
- Viral Kinetics [ Time Frame: up to 24 weeks post treatment ] [ Designated as safety issue: No ]Plasma Ribavirin (RBV) Assays; Immune Response
- Neutrophils [ Time Frame: up to 24-48 weeks of treatment ] [ Designated as safety issue: Yes ]If neutrophils are < 500/mm, neupogen may be added
- Hemoglobin [ Time Frame: up to 24-48 weeks of treatment ] [ Designated as safety issue: Yes ]If hemoglobin is < 100g/L, erythropoietin and/or transfusions may be prescribed
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: Peg-interferon alpha-2a, Ribavirin
Patients will receive PEGASYS® 180 µg in 0.5 mL (prefilled syringes) administered sc once weekly. Specific guidelines for adjusting the dose of PEGASYS® are provided in the product monograph.All PEGASYS® administrations will be via the sc route using sterile technique.
Ribavirin 200 mg tablets
|Centre hospitalier de l'Université de Montréal|
|Montréal, Quebec, Canada, H2X1P1|
|Principal Investigator:||Jean-Pierre Villeneuve, M.D., Ph.D.||Centre Hospitalier de l'Université de Montréal|