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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

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ClinicalTrials.gov Identifier: NCT00606086
Recruitment Status : Completed
First Posted : February 1, 2008
Results First Posted : June 3, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
GlobeImmune

Tracking Information
First Submitted Date  ICMJE January 18, 2008
First Posted Date  ICMJE February 1, 2008
Results First Submitted Date  ICMJE May 5, 2014
Results First Posted Date  ICMJE June 3, 2014
Last Update Posted Date June 27, 2014
Study Start Date  ICMJE December 2007
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2008)
EVR (Early Virologic Response)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Genotype 1 Chronic Hepatitis C
Intervention  ICMJE
  • Drug: GI-5005
    40YU, subcutaneous
    Other Name: Pegasys and Ribavirin
  • Drug: Pegylated Interferon and Ribavirin
    Pegylated interefron is an injection and ribavirin is an oral tablet
    Other Name: Pegasys and Ribavirin
Study Arms  ICMJE
  • Experimental: 1
    GI-5005 monotherapy continuing on to triple therapy
    Intervention: Drug: GI-5005
  • Active Comparator: 2
    Standard of care alone
    Interventions:
    • Drug: GI-5005
    • Drug: Pegylated Interferon and Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2014)
140
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2008)
120
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606086
Other Study ID Numbers  ICMJE GI-5005-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlobeImmune
Study Sponsor  ICMJE GlobeImmune
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GlobeImmune
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP