Hepatitis C Clinical Trial
— ENHANCEOfficial title:
Phase 4 Study Using Infergen and Ribavirin in Patients With Chronic Hepatitis C Virus Who Achieved Partial Response to Peginterferon-alfa and Ribavirin Therapy
Verified date | October 2012 |
Source | Kadmon Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Atlantic Gastroenterology Associates | Atlanta | Georgia |
United States | Liver Institute at Methodist Dallas | Dallas | Texas |
United States | Caroline Digestive Health Associates | Harrisburg | North Carolina |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Kadmon Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks | 1.5 years | No |
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