WHO ICTRP trial
Study of ravulizumab in pediatric participants with HSCT-TMA
EUCTR2020-000761-16-GB · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2020-000761-16-GB |
|---|---|
| Public title | Study of ravulizumab in pediatric participants with HSCT-TMA |
| Scientific title | A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants (from 1 month to < 18 years of age) with Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplantation (HSCT) - Ravulizumab in Pediatric Participants… |
| Primary sponsor | Alexion Pharmaceuticals, Inc. |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;France;Canada;Spain;Germany;Japan;Italy;United Kingdom;Korea, Republic of |
| Conditions | hematopoietic stem cell transplant-associated thrombotic microangiopathy MedDRA version: 20.0 Level: PT Classification code 10043645 Term: Thrombotic microangiopathy System Organ Class: 10005329 - Blood and lymphatic system disorders… |
| Interventions | Trade Name: Ultomiris Product Name: Ultomiris Product Code: ALXN1210 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RAVULIZUMAB CAS Number: 1803171-55-2 Current Sponsor code: ALXN1210 Other descriptive name… |
| Registration date | Aug 19, 2020 |
| Target size | 40 |
| Secondary IDs | ALXN1210-TMA-314;128367 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: