Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124215
Status:
COMPLETED
Last Update Posted:
2010-05-05
First Post:
2005-07-25
Brief Title:
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection
Sponsor:
GlobeImmune
Organization:
GlobeImmune
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 related to the injections
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None