Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy
|ClinicalTrials.gov Identifier: NCT00162734|
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : June 22, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||February 2005|
|Primary Completion Date :||June 2007|
|Study Completion Date :||June 2007|
- 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 ]
- 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. [ Time Frame: 72 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162734
|Study Director:||Ralph T. Doyle||Valeant Pharmaceuticals International, Inc.|