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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03301506 | Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC) | PHASE3 | ACTIVE NOT_RECRUITING | 340 | — | — | Dec 12, 2017 | Dec 1, 2028 | May 4, 2026 | 109 | United States, Argentina +23 |
| Arm | Type | Description |
|---|---|---|
| Seladelpar 5 mg Capsules | EXPERIMENTAL | - |
| Seladelpar 10 mg Capsule | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Seladelpar 5 mg Capsule | DRUG | Participants will be assigned to a treatment group if tolerability issues noted in the previous study. |
| Seladelpar 10 mg Capsule | DRUG | Participants will be assigned to a treatment group unless there are tolerability issues. |
Inclusion Criteria: 1. Must have given written informed consent (signed and dated) 2. Participated in a PBC study with seladelpar 3. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days af...