drugset / Trial / NCT01853254

A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials

NCT01853254

Phase 3 Completed 272 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

Timeline

Start
2003-09
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Subject Ribavirin Small molecule 800 mg Oral
Subject Ribavirin Small molecule 1000 mg Oral
Subject Ribavirin Small molecule 1200 mg Oral