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ClinicalTrials.Gov Identifier: NCT00124215
This study is currently closed.
Summary
The GI-5005 Tarmogen 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 |
|
Hepatitis C Infection |
Therapeutic Vaccine: GI-5005 |
Phase 1b |
| 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
Study Details:
| Expected Total Enrollment: |
72 |
| Study start: |
June, 2005 |
Eligibility
| Eligible Ages: |
18 Years and above |
| Eligible Genders: |
Both |
Inclusion Criteria:
- 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 Criteria:
- Non-responders to previous interferon treatments
- Cirrhosis
- HCV treatment within 3 months
- Hepatitis B infection
- HIV infection
Location and Contact Information:
California
California Pacific Medical Center
The Barry S. Levin, MD Dept of Transplantation
2324 Sacramento Street
San Francisco, CA 94115
| Contact: |
Ellen Hoverson 415.600.1743 |
| Prinicipal Investigator: |
Natalie Bzowej, MD |
Huntington Medical Research Institutes
660 South Fair Oaks Avenue
Pasadena, CA 91105
| Contact: |
Ruth Co 626.397.5825 |
| Prinicipal Investigator: |
Myron Tong, M.D. |
Colorado
University of Colorado Health Sciences Center
4200 E. Ninth Ave., B158
Research Bridge Room #6421
Denver, CO 80262
| Contact: |
Jennifer DeSanto 303-315-1128 |
| Principal Investigator: |
Gregory Everson, M.D. |
Florida
University of Miami
Center for Liver Diseases
1500 NW 12th Avenue, Suite 1101
Miami, FL 33136
| Contact: |
Macy Ho 305.243.4648 |
| Principal Investigator: |
Eugene Schiff, M.D. |
Hawaii
St. Francis Liver Center
Medical Office Building
Suite 306
2228 Liliha Street
Honolulu, HI 96817
| Contact: |
Debbie Bielecki 808.547.6543 |
| Principal Investigator: |
Naoky Tsai, M.D. |
Illinois
University of Chicago
5841 South Maryland Avenue
MC 7120
Chicago, IL 60637
| Contact: |
Katie Wherity 773-702-4477 |
| Principal Investigator: |
Helen Te, M.D. |
| Sub-Investigator: |
Donald Jensen, M.D. |
Massachusetts
Beth Israel Deaconess Medical Center
110 Francis Street, Suite 4A
Boston, MA 02215
| Contact: |
Christine O'Connor 617.632.1051 |
| Principal Investigator: |
Nezam Afdhal, MD |
New York
Weill Medical College of Cornell University
450 East 69th Street
New York, NY 10021
| Contact: |
Maureen Shea 212.746.2133 |
| Principal Investigator: |
Ira Jacobson, M.D. |
North Carolina
Duke Clinical Research Institute
GI/Hepatology
Duke South, Room 0307
Basement, Orange Zone
Durham, NC 27710
| Contact: |
Pat Bixby 919.681.6819 |
| Principal Investigator: |
John McHutchison, MD |
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