Status:
TERMINATED
Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin
Lead Sponsor:
Kadmon Corporation, LLC
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and Ribavirin thera...
Eligibility Criteria
Inclusion
- Male or female, at least 18 years of age and no older than 65 years with compensated chronic HCV infection based on a history of positive serum anti-HCV antibody and/or HCV RNA
- Diagnosed with HCV Genotype 1, 4, 5 or 6 as determined during the screening visit
- The starting doses in the initial treatment must have been 1.5 μg/kg/week PEG-Intron or 180 μg/week Pegasys, and 1000/1200 mg/day ribavirin based on body weight. Patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account.
- Liver biopsy indicating F0-F4 must be performed within 3 years prior to screening. Documentation of the results of the biopsy must be available. If documentation is not available, a liver biopsy must be performed during the screening period. (A maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of F4)
- Documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (PEGASYS) and Ribavirin or peginterferon alfa-2b (Peg-INTRON) and Ribavirin
Exclusion
- Detectable HCV RNA after 12 weeks if initial peginterferon alfa/ribavirin therapy and \<2 log decrease in HCV RNA at Week 12 from baseline.
- HCV Genotype 2 or 3
- Severe neuropsychiatric disorder.
- History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease.
- Known HIV infection or positive HIV at screening.
- Pregnant or breast-feeding patients.
- Underlying autoimmune disease
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00456248
Start Date
February 1 2007
End Date
October 1 2007
Last Update
October 15 2012
Active Locations (4)
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1
Atlantic Gastroenterology Associates
Atlanta, Georgia, United States
2
Tulane University School of Medicine
New Orleans, Louisiana, United States
3
Caroline Digestive Health Associates
Harrisburg, North Carolina, United States
4
Liver Institute at Methodist Dallas
Dallas, Texas, United States