NCT00606086

Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection

A Phase 2 Randomized, Open Label, Multi-center, Therapeutic Trial of the Efficacy, Immunogenicity, and Safety of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone, and GI-5005 Salvage of Standard of Care Failures, in Patients With Genotype 1 Chronic Hepatitis C Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: GlobeImmune · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections including EVR, ETR, and SVR.

Conditions

• Genotype 1 Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	GI-5005	40YU, subcutaneous
DRUG	Pegylated Interferon and Ribavirin	Pegylated interefron is an injection and ribavirin is an oral tablet

Timeline

• Start date: 2007-12-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2008-02-01
• Last updated: 2014-06-27
• Results posted: 2014-06-03

Locations

25 sites across 1 country: United States