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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03588026 | Treating Paroxysmal Nocturnal Haemoglobinuria Patients With rVA576 | PHASE3 | COMPLETED | 9 | — | — | Jun 7, 2018 | Sep 3, 2020 | Apr 9, 2025 | 3 | Kazakhstan, Lithuania +1 |
Haemoglobin stabilisation rate defined as haemoglobin greater than the set point for each patient during the pre-study randomisation period and the avoidance of PRBC transfusions during the treatment period.
| Arm | Type | Description |
|---|---|---|
| Arm 1 - 9 months of treatment (rVA576 plus SOC) | EXPERIMENTAL | 6 months (SOC plus rVA576), Followed by a further 3 months of (SOC plus rVA576). |
| Arm 2 - 6 months on SOC | EXPERIMENTAL | 6 months on SOC only. Followed by 3 months (SOC plus rVA576). |
| Name | Type | Description |
|---|---|---|
| rVA576 | DRUG | 6 months of treatment, rVA576 plus SOC. Followed by a further 3 months of rVA576 plus SOC. In total, 9 months on rVA576 plus SOC. |
| Standard of care (SOC) | OTHER | 6 months on SOC followed by 3 months of treatment with rVA576 plus SOC. In total, 3 months on rVA576 plus SOC. |
Inclusion Criteria: 1. Willing to give informed consent to treatment with rVA576 2. Diagnosed with paroxysmal nocturnal haemoglobinuria (PNH) 3. Have not received any complement inhibitor within the 4 months prior to screening 4. ≥ 18 years of age at the time of screening 5. Weight ≥50kg 6. Complet...