Ribavirin Dose Optimization for the Treatment of Hepatitis C
|ClinicalTrials.gov Identifier: NCT01289496|
Recruitment Status : Completed
First Posted : February 3, 2011
Last Update Posted : February 26, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Peg-interferon alpha-2a, Ribavirin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study|
|Study Start Date :||February 2011|
|Primary Completion Date :||August 2013|
|Study Completion Date :||August 2013|
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
- Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay [ Time Frame: up to 24 weeks post treatment ]Qualitative
- Viral Kinetics [ Time Frame: up to 24 weeks post treatment ]Plasma Ribavirin (RBV) Assays; Immune Response
- Neutrophils [ Time Frame: up to 24-48 weeks of treatment ]If neutrophils are < 500/mm, neupogen may be added
- Hemoglobin [ Time Frame: up to 24-48 weeks of treatment ]If hemoglobin is < 100g/L, erythropoietin and/or transfusions may be prescribed
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289496
|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 (CHUM)|