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

June 17, 2014 updated by: GlobeImmune

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic Torrey Pines
      • San Diego, California, United States, 92105
        • Research and Education Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology
    • Connecticut
      • Farmingtom, Connecticut, United States, 06030
        • University of Connecticut Health Center
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • Georgia
      • Marietta, Georgia, United States, 30060
        • NW Georgia Research Institute
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Medical Center
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Northwest Indiana Center for Clinical Research
    • Louisiana
      • New Orleans, Louisiana, United States
        • Tulane University Hospital
    • Maryland
      • Laurel, Maryland, United States, 20707
        • Maryland Digestive Disease Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Gastroenterology Associates, PA
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • St. Louis University
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • Virginia
      • Newport News, Virginia, United States, 23602
        • Liver Institute of Virginia Bon Secours Health System
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
GI-5005 monotherapy continuing on to triple therapy
Drug: GI-5005
40YU, subcutaneous
Other Names:
  • Pegasys and Ribavirin
Active Comparator: 2
Standard of care alone
Drug: GI-5005
40YU, subcutaneous
Other Names:
  • Pegasys and Ribavirin
Drug: Pegylated Interferon and Ribavirin
Pegylated interefron is an injection and ribavirin is an oral tablet
Other Names:
  • Pegasys and Ribavirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EVR (Early Virologic Response)
Time Frame: At 12 weeks of treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlobeImmune

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (Estimate)

February 1, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI-5005-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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