Ravulizumab in Thrombotic Microangiopathy after Hematopoietic Stem Cell Transplant
Study Identifier:
ALXN1210-TMA-313
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
Recruitment Complete
Study Details
Medical Condition
- Thrombotic Microangiopathy
Study Drug
Date
Dec 2020 - Jun 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 12 - 100 Years
Requirements Information
Sex
Female & Male
Age
12 - 100 Years
Study Details
Medical Condition
- Thrombotic Microangiopathy
Study Drug
Date
Dec 2020 - Jun 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 12 - 100 Years years
Requirements Information
Protocol Summary
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be confirmed. In Stage 2, participants will be randomized to receive either blinded ravulizumab plus best supportive care or matching placebo plus best supportive care. The treatment period is 26 weeks (open-label for Stage 1, and randomized, double-blind, and placebo-controlled for Stage 2) followed by a 26-week follow-up period.
Trial Locations
Location
Status
Location
Research Site
Seoul, Unmapped, 05505
Status
Recruiting
Location
Research Site
Hershey, PA, United States, 17033
Status
Withdrawn
Location
Research Site
Barretos, Unmapped, 14784-400
Status
Recruiting
Location
Research Site
Salerno, Italy, 84100
Status
Recruiting
Location
Research Site
Groningen, Unmapped, 9713 GZ
Status
Active, not recruiting
Location
Research Site
Berlin, Unmapped, D-13353
Status
Recruiting