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Sponsored by: |
GlobeImmune |
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Information provided by: | GlobeImmune |
ClinicalTrials.gov Identifier: | NCT00124215 |
The GI-5005 therapeutic vaccine or placebo will be injected under the skin of hepatitis C virus (HCV) subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections.
Condition | Intervention | Phase |
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Hepatitis C |
Biological: GI-5005 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1 Double-Blind, Placebo Controlled, Dose-Escalation, Multi-Center Therapeutic Trial of the Safety, Immunogenicity, and Efficacy of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, in Patients With Chronic Hepatitis C Infection |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Huntington Medical Research Institutes | |
Pasadena, California, United States, 91105 | |
United States, Colorado | |
University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80262 | |
United States, Florida | |
University of Miami | |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, New York | |
Weill Medical College of Cornell University | |
New York City, New York, United States, 10021 |
Study ID Numbers: | GI-5005-01 |
Study First Received: | July 25, 2005 |
Last Updated: | August 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00124215 |
Health Authority: | United States: Food and Drug Administration |
Hepatitis HCV vaccine Hepatitis C Infection |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
RNA Virus Infections Flaviviridae Infections Infection |