A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Alfacon-1 (Infergen, CIFN) Plus Ribavirin Administered Daily for 48 Weeks Versus No Treatment in Hepatitis C Infected Patients Who Are Nonresponders to Previous Pegylated Interferon Alfa Plus Ribavirin Therapy and During at Least 24 Weeks of No Treatment in IRHC-001
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis C
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 144
- Primary Endpoint
- Evaluate sustained virologic response (SVR) rate of daily Infergen at two dose levels plus ribavirin and no treatment in chronically HCV-infected patients who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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 and participated during at least 24 weeks of no treatment in IRHC-001.
At the time of randomization into IRHC-001, the no treatment arm patients will be concurrently randomized in a 1:1 ration to receive Interferon Alfacon-1 (9 or 15 µg) + Ribavirin (both administered daily) or no treatment for up to 48 weeks. Patients will not be eligible for consideration to receive treatment in IRHC-002 until they have completed a minimum of 24 weeks of participation in IRHC-001.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent form
- •Previously randomized to the No-Treatment Arm in IRHC-001 protocol
- •IRHC-001 no-treatment patients ho have either \< 2 log10 reduction in plasma HCV RNA level by bDNA assay at Week 24 compared to baseline or detectable plasma HCV RNA by bDNA or TMA assays at Week 48
- •All patients and all potentially fertile sexual partners of patients must use 2 reliable forms of effective contraception during the study \& for 6 months after cessation of the study drugs
Exclusion Criteria
- •Patients who experienced hepatic decompensation during IRHC-001 or show laboratory, clinical, or physiologic evidence of hepatic decompensation at screening for IRHC-002
- •Patients who, in the opinion of the Investigator or the Sponsor, are not suitable candidates for enrollment or who would not comply w/the requirements of the study
- •Pregnant or lactating women
- •Male partners of women who are pregnant
- •Patients who were on any experimental protocols or therapy while participating in IRHC-001
Outcomes
Primary Outcomes
Evaluate sustained virologic response (SVR) rate of daily Infergen at two dose levels plus ribavirin and no treatment in chronically HCV-infected patients who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy.
Time Frame: 72 weeks
Secondary Outcomes
- Evaluate safety & tolerability of therapy detailed in primary objective, and proportion of patients with (a) undetectable plasma HCV RNA levels at weeks 24 & 48 (b) abnormal baseline serum ALT levels that are normal at week 24, week 48 and weeks 48 & 72.(72 weeks)