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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02027116 | Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection | PHASE1 | COMPLETED | 18 | — | — | Jan 1, 2014 | Jul 1, 2017 | Aug 7, 2017 | 2 | South Korea |
To evaluate the safety and tolerability of VGX-6150 as second-line therapy in chronic hepatitis C patients.
| Arm | Type | Description |
|---|---|---|
| Experimental: 1mg of DNA/dose | EXPERIMENTAL | Subjects will receive a 3 dose series of VGX-6150 containing 1mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12 |
| Experimental: 3mg of DNA/dose | EXPERIMENTAL | Subjects will receive a 3 dose series of VGX-6150 containing 3mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12 |
| Experimental: 6mg of DNA/dose | EXPERIMENTAL | Subjects will receive a 3 dose series of VGX-6150 containing 6mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12 |
| Name | Type | Description |
|---|---|---|
| VGX-6150 | BIOLOGICAL | Plasmid DNA delivered via IM injection with electroporation |
Inclusion Criteria: * Subjects who want to participate in this trial should meet all of the following criteria. 1. Male or females aged 19 to 65 years 2. Chronic hepatitis C patients infected with HCV genotype 1a or 1b 3. Patients who failed\* SOC therapy with PEG-IFN and ribavirin or triple...