NCT01137383

Pegaferon and Ribavirin for Hepatitis C

Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using standard guidelines for hepatitis C. Response to treatment and side effects will be recorded.

Detailed description

The product is locally produced and needs to be evaluated in terms of efficacy and safety.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Pegaferon (pegylated interferon alpha 2a) + ribavirin	pegylated interferon 180 micrograms subcutaneously weekly - ribavirin (oral, in two divided daily doses) 800 mg for genotype 2 and 3, 1000 or 1200mg (weight less than or greater than 75kg) for genotypes 1 and 4 - Duration: 24 weeks for genotype 2 and 3, 48 weeks for genotypes 1 and 4

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2010-06-04
• Last updated: 2010-06-30

Locations

2 sites across 1 country: Iran