An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome
Latest Information Update: 03 Nov 2023
At a glance
- Drugs Eculizumab (Primary)
- Indications Atypical Haemolytic Uraemic Syndrome
- Focus Therapeutic Use
- Sponsors Alexion Pharmaceuticals
- 12 Dec 2021 Results of patient-level data from four eculizumab clinical trials (C08-002A/B (NCT00844545/NCT00844844), C10-003 (NCT01193348), and C10-004 (NCT01194973) were available for pooling and comparison with data from two ravulizumab trials (ALXN-aHUS-311 (NCT02949128) and ALXN-aHUS-312 (NCT03131219) assessing the effectiveness of ravulizumab and eculizumab for the treatment of aHUS, accounting for observed differences between clinical studies, published in the Clinical Nephrology.
- 05 May 2014 The US FDA has approved Alexion Pharmaceuticals' supplemental Biologics License Application (sBLA) providing regular approval for eculizumab; regular approval includes data from this study.
- 10 Dec 2013 Results presented at the 55th Annual Meeting and Exposition of the American Society of Hematology.