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:
N/A
Recruitment Complete

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
Tampa, Florida, United States, 33612
Status
N/A
Location
Research Site
Atlanta, Georgia, United States, 30322
Status
N/A
Location
Research Site
Boston, Massachusetts, United States, 02215
Status
N/A
Location
Research Site
Grosse Pointe Farms, Michigan, United States, 48236
Status
N/A
Location
Research Site
Durham, North Carolina, United States, 27705
Status
N/A
Location
Research Site
Columbus, Ohio, United States, 43210
Status
N/A