NCT01289496

Ribavirin Dose Optimization for the Treatment of Hepatitis C

Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Peg-interferon alpha-2a, Ribavirin	* 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

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-02-03
• Last updated: 2014-02-26

Locations

1 site across 1 country: Canada