Virological Response Study of the HCV Vaccine IC41 - Full Text View

Purpose

The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41.

Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.

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, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Open-Label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV

Further study details as provided by Intercell AG:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	70
Study Start Date:	February 2006
Estimated Study Completion Date:	July 2008

Intervention Details:

injection

Eligibility

Criteria

Inclusion Criteria:

Written informed consent obtained prior to study entry
Patients with chronic hepatitis C; genotype 1
Treatment naive patients
Male and Female, 18 to 55 years
Presence of HLA-A2 marker
Mentally healthy
No clinically relevant pathological findings in any of the investigations at screening
Treatment naive patients with chronic Hepatitis C of genotype 1

Exclusion Criteria:

Positive results in HIV, HBsAg and HAV-Ag (IgM)
Other causes of chronic hepatitis
History of autoimmune diseases
Previous vaccination with any prophylactic or therapeutic Hepatitis C vaccine (in a clinical study)
Active or passive vaccination 4 weeks before and during the entire study period
Decompensated liver disease
History of severe hypersensitivity reactions and anaphylaxis
Known allergic reactions to one of the components of the vaccine and Imiquimod cream
Clinically significant diseases which, in the opinion of the Investigator, might lead to frequent hospitalization/medical attendance
Malignancies
Immunosuppressive therapy
Pregnancy, lactation or breast-feeding
Unwillingness to practice appropriate contraception
Participation in another study with an investigational drug within 1 month prior to enrolment and the entire study period
Patients, who in the opinion of the Investigator, might not be able to comply with the study protocol (e.g.: Drug addiction, alcoholism)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601770

Sponsors and Collaborators

Intercell AG

Investigators


Study Director:	Dagmar Friede, Ph.D.	Intercell AG

More Information

Responsible Party:	Intercell AG ( Intercell AG )
Study ID Numbers:	IC41-202
First Received:	January 4, 2008
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00601770
Health Authority:	Germany: Paul-Ehrlich-Institut; Romania: Ministry of Public Health; 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 October 28, 2008

Sponsored by:	Intercell AG
Information provided by:	Intercell AG
ClinicalTrials.gov Identifier:	NCT00601770