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      Withdrawn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