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

NCT ID: NCT00606086

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-11-30

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.

Conditions

Genotype 1 Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

GI-5005 monotherapy continuing on to triple therapy

Group Type: EXPERIMENTAL

GI-5005

Intervention Type: DRUG

40YU, subcutaneous

2

Standard of care alone

Group Type: ACTIVE_COMPARATOR

GI-5005

Intervention Type: DRUG

40YU, subcutaneous

Pegylated Interferon and Ribavirin

Intervention Type: DRUG

Pegylated interefron is an injection and ribavirin is an oral tablet

Interventions

GI-5005

40YU, subcutaneous

Intervention Type: DRUG

Pegylated Interferon and Ribavirin

Pegylated interefron is an injection and ribavirin is an oral tablet

Intervention Type: DRUG

Other Intervention Names

Pegasys and Ribavirin; Pegasys and Ribavirin

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlobeImmune

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

GI-5005-02

Identifier Type: -

Identifier Source: org_study_id