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Sponsored by: |
GlobeImmune |
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Information provided by: | GlobeImmune |
ClinicalTrials.gov Identifier: | NCT00606086 |
The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections including EVR, ETR, and SVR.
Condition | Intervention | Phase |
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Genotype 1 Chronic Hepatitis C |
Drug: GI-5005 Drug: Pegylated Interferon and Ribavirin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 120 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
GI-5005 monotherapy continuing on to triple therapy
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Drug: GI-5005
40YU, subcutaneous
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2: Active Comparator
Standard of care alone
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Drug: GI-5005
40YU, subcutaneous
Drug: Pegylated Interferon and Ribavirin
Pegylated interefron is an injection and ribavirin is an oral tablet
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Non-Responders
Naive
Exclusion Criteria:
Responsible Party: | GlobeImmune, Inc. ( John Ferraro MBA Director Clinical Operations ) |
Study ID Numbers: | GI-5005-02 |
Study First Received: | January 18, 2008 |
Last Updated: | January 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00606086 |
Health Authority: | United States: Food and Drug Administration |
Hepatitis, HCV, Liver disease, HepC |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Interferons |
Ribavirin Peginterferon alfa-2a Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections |
Antineoplastic Agents Therapeutic Uses Antiviral Agents Pharmacologic Actions |