Virological Response Study of the HCV Vaccine IC41 - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 4, 2008

Last Updated Date

January 15, 2008

Start Date ^†

February 2006

Current Primary Outcome Measures ^†

HCV-RNA 2 weeks after end of treatment

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00601770 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Immunological assays and Safety

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Virological Response Study of the HCV Vaccine IC41

Official Title ^†

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Chronic Hepatitis C

Intervention ^†

Biological: IC41

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

Estimated Completion Date

July 2008

Primary Completion Date

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)

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00601770

Responsible Party

Intercell AG, Intercell AG

Secondary IDs ^††

Study Sponsor ^†

Intercell AG

Collaborators ^††

Investigators ^†

Study Director:

Dagmar Friede, Ph.D.

Intercell AG

Information Provided By

Intercell AG

Verification Date

October 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.