Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of
two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily
for 48 weeks and no treatment in patients chronically infected with hepatitis C who are
nonresponders to previous pegylated interferon alfa plus ribavirin therapy.
Patients are randomized 1:1:1 to receive Interferon Alfacon-1 (9 or 15 µg) + Ribavirin (both
administered daily) or no treatment for up to 48 weeks.
The protocol and informed consent form that will be used must be approved by the
Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the
study is initiated.
Phase:
Phase 3
Details
Lead Sponsor:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.