Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162734
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2005-09-08
Brief Title:
Daily-Dose Consensus Interferon and Ribavirin Efficacy of Combined Therapy
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 Investigators Institutional Review Board IRBIndependent Ethics Committee IEC before the study is initiated
At the time of randomization into IRHC-001 the no treatment arm patients will be concurrently randomized in a 11 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 Investigators Institutional Review Board IRBIndependent Ethics Committee IEC before the study is initiated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DIRECT 2 | None | None | None |