Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin
Information source: Kadmon Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C
Intervention: Infergen and ribavirin (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Kadmon Pharmaceuticals Official(s) and/or principal investigator(s): Mitchell L Schiffman, MD, Principal Investigator, Affiliation: Virginia Commonwealth University
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Atlantic Gastroenterology Associates, Atlanta, Georgia, United States
Tulane University School of Medicine, New Orleans, Louisiana, United States
Caroline Digestive Health Associates, Harrisburg, North Carolina, United States
Liver Institute at Methodist Dallas, Dallas, Texas, United States
Additional Information
Starting date: February 2007
Last updated: October 11, 2012
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