Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine
This study has been completed.
Sponsored by: Intercell AG
Information provided by: Intercell AG
ClinicalTrials.gov Identifier: NCT00602784
  Purpose

The objectives are

  1. to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization with HCV antigen peptide vaccine with polyarginine.
  2. to document virological (HCV-RNA) and biochemical (ALT) responses following immunization with HCV antigen peptide vaccine with polyarginine.
  3. to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.

Condition Intervention Phase
Chronic Hepatitis C
Biological: IC41
Phase II

MedlinePlus related topics: Hepatitis Hepatitis C
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Double-Blind, Parallel Assignment
Official Title: Double Blind, Randomized, Multicenter, Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine Together With Polyarginine, HCV Peptide Vaccine Alone, or Polyarginine Alone, in Patients With Chronic HCV Having Not Responded to or Relapsed From Primary Standard HCV Therapy

Further study details as provided by Intercell AG:

Primary Outcome Measures:
  • Immunological assays and Safety

Enrollment: 66
Study Start Date: November 2002
Study Completion Date: May 2004
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic hepatitis C
  • Non-response to or relapse from primary standard HCV therapy
  • HLA A2 positive
  • HCV-RNA positive
  • HCV antibodies positive
  • Liver biopsy within 30 months prior to inclusion
  • Hematology and biochemistry laboratory results within the limits normally expected for the patient population (liver values maximal 5 times the upper limit of normal)
  • Male and female
  • From 18 to 65 years
  • Written informed consent obtained prior to study entry

Exclusion Criteria:

  • Any degree of liver cirrhosis or fibrosis of Ishak score ≥ 4 (for grading table, see APPENDIX 2: The Ishak Modified Hepatic Activity Index (HAI))
  • Any liver disease other than hepatitis C
  • History of autoimmune disease
  • Immunodeficiency including post-organ-transplantation
  • HIV infection
  • Immunosuppressive therapy
  • Any acute infections within 4 weeks prior to inclusion
  • History of severe hypersensitivity reactions, anaphylaxis or atopy
  • Diabetes mellitus, severe cardiopulmonary disorders, history of malignancy in the past 5 years
  • Active or passive vaccination within 2 months prior to enrolment, and concomitant vaccination throughout the study period
  • Pregnancy or lactation
  • Unreliable contraception
  • Alcohol consumption
  • Drug abuse or addiction within 12 months prior to inclusion
  • Participation in a methadone program
  • Participation in another study within 1 month prior to enrolment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602784

Sponsors and Collaborators
Intercell AG
Investigators
Study Director: Erich Tauber, M.D. Intercell AG
  More Information

Responsible Party: Intercell AG
Study ID Numbers: IC41-201
Study First Received: January 4, 2008
Last Updated: January 15, 2008
ClinicalTrials.gov Identifier: NCT00602784  
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen;   Germany: Paul-Ehrlich-Institut;   Poland: Ministry of Health

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 14, 2009