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Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial

NCT00211692 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-11-21

Study results available
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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.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

consensus interferon (Interferon Alfacon-1) and ribavirin

CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B)

DRUG

Consensus Interferon alfa (CIFN) and ribavirin

CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B)

Sponsors & Collaborators

  • Center for Veterans Research and Education

    collaborator OTHER

  • InterMune

    collaborator INDUSTRY

  • Kadmon Corporation, LLC

    collaborator INDUSTRY

  • US Department of Veterans Affairs

    collaborator FED

  • San Diego Veterans Healthcare System

    collaborator FED

  • Minneapolis Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Samuel B. Ho, M.D. · US Department of Veterans Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2008-07-31
Completion
2009-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00211692 on ClinicalTrials.gov