Status:
COMPLETED
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection
Lead Sponsor:
GlobeImmune
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 rel...
Eligibility Criteria
Inclusion
- Patients with chronic hepatitis C virus infection including treatment naive subjects as well as subjects who are partial responders and relapsers to prior interferon therapy
- \>18 years of age
- Negative skin test for hypersensitivity to saccharomyces cerevisiae.
Exclusion
- Non-responders to previous interferon treatments
- Cirrhosis
- HCV treatment within 3 months
- Hepatitis B infection
- HIV infection
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00124215
Start Date
June 1 2005
End Date
February 1 2010
Last Update
May 5 2010
Active Locations (5)
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1
Huntington Medical Research Institutes
Pasadena, California, United States, 91105
2
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
3
University of Miami
Miami, Florida, United States, 33136
4
University of Chicago
Chicago, Illinois, United States, 60637