Ribavirin Dose Optimization for the Treatment of Hepatitis C
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|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|
|Actual Primary Completion Date :||August 2013|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|