Status:
COMPLETED
Study of High Dosage CIFN Plus RBV for HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Therapy
Lead Sponsor:
Beth Israel Medical Center
Collaborating Sponsors:
InterMune
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The main purpose of this study is to evaluate the safety and tolerability of combination therapy of daily interferon alfacon-1 (Infergen, CIFN) at high dosage (24 mcg) with ribavirin (based on body we...
Eligibility Criteria
Inclusion
- Must have documented failure to respond to past treatment with a Pegylated IFN + RBV. Failure to respond to past treatment is defined as positive HCV RNA at 12 weeks and less than a 2 log drop from baseline; OR positive HCV RNA and greater than 2 log drop from baseline at week 12 and must have received 24 weeks of therapy and still have a positive HCV RNA
- Must have tolerated previous hepatitis C therapy
- Must be off hepatitis C therapy for 3 months prior to study participation
- Must have had a liver biopsy within the past 5 years
Exclusion
- Decompensated liver disease
- Laboratory abnormalities as per protocol
- HIV+
- Autoimmune disease
- Unstable or deteriorating cardiovascular or cerebrovascular disease
- History of seizures in past 5 years
- Alcohol or drug abuse in past year
- Pregnant or lactating women
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00266318
Start Date
December 1 2005
End Date
May 1 2007
Last Update
April 17 2008
Active Locations (1)
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1
Beth Israel Medical Center
New York, New York, United States, 10003