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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05876351 | Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China | PHASE3 | COMPLETED | 25 | — | — | Jul 14, 2023 | May 7, 2025 | Dec 8, 2025 | 6 | China |
The criteria for complete TMA response were: 1. Normalization of platelet count (defined as platelet count ≥ 150000/microliter (ul). 2. Normalization of lactate dehydrogenase (LDH, defined as LDH ≤ upper limit of normal \[ULN\]). 3. ≥ 25% improvement in serum creatinine from baseline.
| Arm | Type | Description |
|---|---|---|
| Eculizumab | EXPERIMENTAL | Participants will receive Eculizumab in a single dose vial. |
| Name | Type | Description |
|---|---|---|
| Eculizumab | DRUG | Weight-based doses of Eculizumab will be administered intravenously as an induction dose followed by maintenance dose at Day 8, 15, or 29 depending on weight; then every 2 or 3 weeks, depending upon weight. |
Inclusion Criteria: 1. Any age weighing ≥ 5 kg 2. Complement treatment naïve with evidence of TMA. 3. History of aHUS prior to kidney transplant,or persistent evidence of TMA at least 4 days after modifying the immunosuppressive regimen. 4. Among participants with onset of TMA postpartum, persisten...