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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02227459 | Phase 1b/2, Open Label, Repeat Dose, Dose Escalation Study of ND-L02-s0201 Injection in Subjects With Moderate to Extensive Fibrosis (METAVIR F3-4) | PHASE1 | COMPLETED | 25 | — | — | Oct 1, 2014 | May 1, 2016 | May 11, 2017 | 2 | United States, Bulgaria |
| Arm | Type | Description |
|---|---|---|
| Experimental: Arm A | EXPERIMENTAL | Once a week dosing |
| Experimental: Arm B | EXPERIMENTAL | Twice a week dosing |
| Name | Type | Description |
|---|---|---|
| ND-L02-s0201 Injection | DRUG | - |
Inclusion Criteria: 1. Male or female between 18 and 75 years 2. Diagnosis of METAVIR F3-4 hepatic fibrosis determined by liver biopsy done within 12 months before screening (Cohort 1) or at the pre-dose biopsy within 6 weeks before treatment (Cohorts 2 and 3) 3. Adequate and stable synthetic hepat...