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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03501550 | Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL) | PHASE2 | COMPLETED | 12 | — | — | Jun 26, 2018 | Jun 7, 2019 | Apr 28, 2021 | 1 | United States |
The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after treatment
| Arm | Type | Description |
|---|---|---|
| CDI-31244 + SOF/VEL | EXPERIMENTAL | CDI-31244 in combination with SOF/VEL |
| Name | Type | Description |
|---|---|---|
| CDI-31244 | DRUG | investigational drug |
| SOF/VEL | DRUG | sofosbuvir and velpatasvir fixed dose combination |
Key Inclusion Criteria: Documented chronic HCV GT 1 infection; Serum HCV RNA \>1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis Key Exclusion Criteria: Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of a...