E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic Hepatitis C (HCV) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the virological (HCV-RNA) responses following biweekly immunisation with IC41. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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)
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E.5 End points |
E.5.1 | Primary end point(s) |
Decline of HCV-RNA during and up to two weeks after end of treatment Visit 9 (Week 16) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |