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:
Recruiting
Study Details
Medical Condition
- Unmapped
Study Drug
- Biological: Ravulizumab
Date
Dec 2020 - Apr 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
- Unmapped
Study Drug
- Biological: Ravulizumab
Date
Dec 2020 - Apr 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
Birmingham, Alabama, United States, 35233
Status
Withdrawn
Location
Research Site
Tucson, Arizona, United States, 85724
Status
Withdrawn
Location
Research Site
Tampa, Florida, United States, 33612
Status
Recruiting
Location
Research Site
Atlanta, Georgia, United States, 30322
Status
Recruiting
Location
Research Site
Chicago, Illinois, United States, 60611
Status
Withdrawn
Location
Research Site
Chicago, Illinois, United States, 60637
Status
Withdrawn