A Phase 2 Randomized, Open Label, Multi-Center, Therapeutic Trial of the Efficacy, Immunogenicity, and Safety of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone, and GI-5005 Salvage of Standard of Care Failures, in Patients With Genotype 1 Chronic Hepatitis C Infection.

Trial Profile

A Phase 2 Randomized, Open Label, Multi-Center, Therapeutic Trial of the Efficacy, Immunogenicity, and Safety of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone, and GI-5005 Salvage of Standard of Care Failures, in Patients With Genotype 1 Chronic Hepatitis C Infection.

Completed
Phase of Trial: Phase II

Latest Information Update: 14 Jul 2014

At a glance

  • Drugs GI 5005 (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Pharmacodynamics; Pharmacogenomic; Therapeutic Use
  • Sponsors GlobeImmune
  • Most Recent Events

    • 01 Nov 2010 Results reported at the Annual Meeting of the American Association for the Study of the Liver Diseases, according to a GlobeImmune media release.
    • 28 Oct 2010 An open-label extension of this trial will include an additional 40 treatment-naive IL28B T/T patients with chonic genotype 1 hepatitis C virus according to a GlobeImmune media release.
    • 05 Oct 2010 Planned end date changed from 1 Jan 2011 to 1 Oct 2012 as reported by ClinicalTrials.gov.
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