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

Completed · Phase 2

Conditions studied: Genotype 1 Chronic Hepatitis C

In brief

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.

Key facts

Study ID: NCT00606086
Run by: GlobeImmune
People needed: 140
Starts: 2007-12-01
Expected to finish: 2012-11-01
Last updated by the study team: 2014-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;

Where it is running

University of Alabama Birmingham — Birmingham, Alabama, United States
University of Arizona — Tucson, Arizona, United States
Scripps Clinic Torrey Pines — La Jolla, California, United States
Research and Education inc. — San Diego, California, United States
University of Colorado — Aurora, Colorado, United States
South Denver Gastroenterology — Englewood, Colorado, United States
University of Connecticut Health Center — Farmingtom, Connecticut, United States
Yale University School of Medicine — New Haven, Connecticut, United States
NW Georgia Research Institute — Marietta, Georgia, United States
Hawaii Medical Center — Honolulu, Hawaii, United States
Northwest Indiana Center for Clinical Research — Valparaiso, Indiana, United States
Tulane University Hospital — New Orleans, Louisiana, United States
Maryland Digestive Disease Research — Laurel, Maryland, United States
Henry Ford Health System — Detroit, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
Gastroenterology Associates, PA — Jackson, Mississippi, United States
St. Louis University — St Louis, Missouri, United States
Weill Medical College of Cornell University — New York, New York, United States
Columbia University — New York, New York, United States
Duke University — Durham, North Carolina, United States
University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
Baylor College of Medicine — Houston, Texas, United States
Alamo Medical Research — San Antonio, Texas, United States
Liver Institute of Virginia Bon Secours Health System — Newport News, Virginia, United States
McGuire VA Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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