chronic Hepatitis C (HCV)
Conditions
Interventions
Product Name: IC41
Pharmaceutical Form: Suspension for injection
Sponsors
Intercell AG
Eligibility
Sex/Gender
All
Inclusion 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 the V0 visit. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the virological (HCV-RNA) responses following biweekly immunisation with IC41.;Secondary Objective: To investigate the virological (HCV-RNA)) responses following weekly immunisation with IC41. To assess the safety of immunization with IC41. To assess immunological T-cell responses to IC41. ;Primary end point(s): Decline of HCV-RNA during and up to two weeks after end of treatment Visit 9 (Week 16) | — |
Countries
Germany
Outcome results
None listed