Status:
COMPLETED
Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 an...
Eligibility Criteria
Inclusion
- (Abbreviated due to space constraints.)
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00162734
Start Date
February 1 2005
End Date
June 1 2007
Last Update
June 22 2012
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