At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 140 enrolled
Drug / intervention
GI-5005 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GI-5005 and Pegylated Interferon and Ribavirin for Genotype 1 Chronic Hepatitis C. Completed, enrolled 140 participants across 25 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenotype 1 Chronic Hepatitis C
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedFeb 2008
Primary CompletionNov 2012
TodayJul 2026
First PostedFeb 1, 2008
Enrollment StartDec 1, 2007
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.4 years ago
Interventions
GI-5005drug
40YU, subcutaneous
Pegylated Interferon and Ribavirindrug
Pegylated interefron is an injection and ribavirin is an oral tablet