Trials / Completed
CompletedNCT00124215
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- GlobeImmune · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 related to the injections.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GI-5005 | Heat-killed yeast cell transfected with NS3-Core fusion protien. |
Timeline
- Start date
- 2005-06-01
- Primary completion
- 2007-06-01
- Completion
- 2010-02-01
- First posted
- 2005-07-27
- Last updated
- 2010-05-05
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00124215. Inclusion in this directory is not an endorsement.