Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, Liver, Pegylated, Interferon, Ribavirin, Combination, Nonresponder, Relapser, HCV, Infergen, SVR
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 therapy. The study will be conducted at approximately 50 sites across the United States.
Interventions
DRUGInfergen and ribavirin
Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks
Sponsors
Kadmon Corporation, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the proportion of patients with a sustained viral response (SVR) defined as undetectable serum HCV RNA at the end of the 24 week post-treatment follow-up period. | 1.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks | 1.5 years |
Countries
United States
Outcome results
None listed