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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02598583 | Dose-Escalation Study of ALXN1210 IV in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) | PHASE1 | COMPLETED | 13 | — | — | Nov 12, 2015 | Mar 11, 2021 | May 16, 2022 | 8 | Australia, South Korea |
Baseline was defined as the average of all available assessments prior to first ALXN1210 infusion.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants were administered ALXN1210 900 mg. In the Extension period participants continued at the same dose and frequency as the Primary Evaluation Period. |
| Cohort 2 | EXPERIMENTAL | Participants were administered ALXN1210 1800 mg. In the Extension period participants continued at the same dose and frequency as the Primary Evaluation Period. |
| Name | Type | Description |
|---|---|---|
| ALXN1210 | BIOLOGICAL | Participants were administered ravulizumab as an IV infusion every 4 weeks. |
Inclusion Criteria: 1. Male or female ≥18 years of age 2. PNH diagnosis confirmed by documented high-sensitivity flow cytometry 3. Documented meningococcal vaccination not more than 3 years prior to dosing 4. Female participants of childbearing potential used highly effective contraception starting...