Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kadmon Corporation, LLC
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
