Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial
Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
Data have suggested that consensus interferon (CIFN) has greater antiviral activity in vitro
compared with interferon alfa-2a or alfa-2b. Several clinical studies also suggest that CIFN
has greater antiviral activity in patients with genotype 1 hepatitis C infection,
particularly if given as a daily injection. These data indicate that the use of a regimen of
daily CIFN and ribavirin will lead to greater virologic response rates compared with
pegylated interferon alfa-2b and ribavirin in patients with genotype 1 infection, with
comparable adverse events. Emerging data indicate that HCV genotype 1 patients with a delayed
virologic response to initial therapy may benefit from an extended duration of therapy.
Therefore, the goals of this pilot study are to determine the tolerability and efficacy of
daily CIFN plus ribavirin when given for 52 weeks or an extended duration of therapy. The
target population will consist of "difficult-to-treat" patients, defined as having the
following characteristics: genotype 1, a North American patient population, predominantly
male gender, and no specific exclusions for pre-existing psychiatric or substance abuse
co-morbidities.
Phase:
Phase 3
Details
Lead Sponsor:
Minneapolis Veterans Affairs Medical Center
Collaborators:
Center for Veterans Research and Education InterMune Kadmon Pharmaceuticals Minnesota Veterans Medical Research and Education Foundation San Diego Veterans Healthcare System US Department of Veterans Affairs VA Office of Research and Development