Safety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection

NCT ID: NCT00124215

Last Updated: 2010-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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GI-5005

Heat-killed yeast cell transfected with NS3-Core fusion protien.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlobeImmune

INDUSTRY

Sponsor Role lead

Responsible Party

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GlobeImmune, Inc.

Locations

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Huntington Medical Research Institutes

Pasadena, California, United States

Site Status

University of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Weill Medical College of Cornell University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GI-5005-01

Identifier Type: -

Identifier Source: org_study_id

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