At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study
In Brief
A Phase 2 clinical trial evaluating Peg-interferon alpha-2a, Ribavirin for Chronic Hepatitis C. Completed, enrolled 13 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
* 4 weeks RBV priming; * 24 or 48 weeks of Pegasys+Ribavirin (RBV) Treatment (depending on genotype); * 24 weeks Follow-Up 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