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
1 other identifier
interventional
140
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2007
Longer than P75 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 18, 2008
CompletedFirst Posted
Study publicly available on registry
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
June 3, 2014
CompletedJune 27, 2014
May 1, 2014
4.9 years
January 18, 2008
May 5, 2014
June 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EVR (Early Virologic Response)
Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.
At 12 weeks of treatment
Study Arms (2)
1
EXPERIMENTALGI-5005 monotherapy continuing on to triple therapy
2
ACTIVE COMPARATORStandard of care alone
Interventions
Pegylated interefron is an injection and ribavirin is an oral tablet
Eligibility Criteria
You may qualify if:
- Chronic hepatitis C infection with genotype 1 based on serum positivity for HCV RNA or a positive test for serum anti-HCV antibody for at least 6 months;
- One of the following response criteria based on response to prior combination therapy with pegylated or non-pegylated interferon plus ribavirin:
- Non-Responders
- Poor responders - a subset of non-responders who achieved \> 1 log10 but \< 2 log10 reduction in HCV RNA after a minimum of 12 weeks of prior interferon based therapy.
- Partial responders - a subset of non-responders who achieve at least a 2 log10 reduction in HCV RNA by 12 weeks, but do not achieve an end of treatment response (ETR defined as HCV RNA negativity by PCR assay at the end of a minimum of 6 months of therapy).
- Naive
- Patients who are treatment naïve and have refused IFN therapy for reasons other than contraindication.
- Signed, written, informed consent from the patient or legal representative before any study-specific procedures are performed;
- Liver biopsy within 3 years of the screening visit, documenting extent of liver disease consistent with chronic hepatitis C with evidence of inflammation and/or fibrosis. Liver biopsy within 1 year for subjects consenting to paired biopsy testing. Eight unstained liver biopsy slides are required for the baseline sample and post-treatment sample for use in central blinded evaluation for paired biopsy testing;
- Age ≥ 18 years;
- Negative scratch test (immediate hypersensitivity, IgE mediated) to S. cerevisiae.
You may not qualify if:
- History of decompensated liver disease, including but not restricted to, portal hypertension as manifested by a known history of gastroesophageal varices, variceal bleeding, ascites or encephalopathy, histopathologic or clinical evidence of cirrhosis, hepatocellular carcinoma, or renal impairment consistent with hepatorenal syndrome;
- History of significant non-HCV chronic liver disease, i.e. alcoholic hepatitis, autoimmune hepatitis;
- Null response to prior IFN plus ribavirin therapy, defined as patients that have received at least 12 weeks of interferon-based treatment with \< 1 log10 reduction in viral load;
- Subjects treated with more than 1 complete hepatitis C regimen (subjects with a history of 1 complete prior regimen and a second incomplete prior regimen may be eligible upon discussion with and approval of the medical monitor);
- Subjects that required a dose reduction of \>25% of the planned exposure of IFN or \>50% of their planned ribavirin exposure during their previous interferon/ribavirin treatment;
- Subjects that required growth factors during their previous interferon/ribavirin treatment;
- Subjects that received small molecule inhibitor therapy combined with an interferon based regimen. (subjects that received small molecule inhibitor monotherapy can be included);
- Treatment for HCV infection within 28 days before screening;
- Chronic hepatitis B infection or positive hepatitis B surface antigen (HBsAg) at screening;
- Body weight \>275 pounds;
- Known history of HIV infection or positive HIV antibody test at screening;
- History of Crohn's disease or ulcerative colitis;
- Concurrent therapy with herbal supplements taken specifically for the treatment of HCV (i.e. milk thistle). Wash-out of HCV related herbals for 28 days prior to Day 1. Consult sponsor before excluding potential subjects;
- Alcohol and/or IV drug abuse within the past year;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlobeImmunelead
Study Sites (25)
University of Alabama Birmingham
Birmingham, Alabama, 35294, United States
University of Arizona
Tucson, Arizona, 85724, United States
Scripps Clinic Torrey Pines
La Jolla, California, 92037, United States
Research and Education inc.
San Diego, California, 92105, United States
University of Colorado
Aurora, Colorado, 80045, United States
South Denver Gastroenterology
Englewood, Colorado, 80113, United States
University of Connecticut Health Center
Farmingtom, Connecticut, 06030, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
NW Georgia Research Institute
Marietta, Georgia, 30060, United States
Hawaii Medical Center
Honolulu, Hawaii, 96817, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383, United States
Tulane University Hospital
New Orleans, Louisiana, United States
Maryland Digestive Disease Research
Laurel, Maryland, 20707, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Gastroenterology Associates, PA
Jackson, Mississippi, 39202, United States
St. Louis University
St Louis, Missouri, 63104, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Columbia University
New York, New York, 10032, United States
Duke University
Durham, North Carolina, 27710, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Liver Institute of Virginia Bon Secours Health System
Newport News, Virginia, 23602, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Operations Manager
- Organization
- GlobeImmune, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2008
First Posted
February 1, 2008
Study Start
December 1, 2007
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
June 27, 2014
Results First Posted
June 3, 2014
Record last verified: 2014-05