Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00601770 | Virological Response Study of the HCV Vaccine IC41 | PHASE2 | COMPLETED | 71 | — | — | Feb 1, 2006 | Jul 1, 2008 | Feb 11, 2014 | 8 | Germany, Poland +1 |
| NCT00602784 | Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine | PHASE2 | COMPLETED | 66 | — | — | Nov 1, 2002 | Sep 1, 2004 | Oct 19, 2012 | - | — |
| Arm | Type | Description |
|---|---|---|
| IC41 | EXPERIMENTAL | 8 injections of 4 x 0.125mL |
| IC41-B-01/02 | EXPERIMENTAL | peptide dose 0.00 mg, polyarginine dose 2.00 mg |
| IC41-C-01/02 | EXPERIMENTAL | peptide dose: 5.00 mg, polyarginine dose: 0.00 mg |
| IC41-G-01/02 | EXPERIMENTAL | peptide dose: 2.50 mg, polyarginine dose: 1.25 mg |
| IC41-H-01/02 | EXPERIMENTAL | peptide dose: 2.50 mg, polyarginine dose: 2.00 mg |
| IC41-K-01/02 | EXPERIMENTAL | peptide dose: 5.00 mg, polyarginine dose: 2.00 mg |
| Name | Type | Description |
|---|---|---|
| IC41 | BIOLOGICAL | injection |
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 inves...