Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger

Study Identifier:
ALXN1210-TMA-315
ClinicalTrials.gov Identifier:
NCT04743804
EudraCT Identifier:
2020-005328-13
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Available Documents

ProtocolStatistical Analysis Plan

Study Details

Medical Condition
  • Thrombotic Microangiopathy
Study Drug
  • Biological: Ravulizumab
Date
Jun 2021 - Dec 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Thrombotic Microangiopathy
Study Drug
  • Biological: Ravulizumab
Date
Jun 2021 - Dec 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information

Protocol Summary

This study will investigate the efficacy and safety of ravulizumab compared to placebo in adult participants with thrombotic microangiopathy (TMA) associated with a trigger. Participants will be randomized to receive either ravulizumab plus best supportive care or placebo plus best supportive care. The treatment period is 26 weeks followed by a 26-week off-treatment follow-up period.

Trial Locations

Location
Status
Location
Research Site
Tucson, Arizona, United States, 85724
Status
N/A
Location
Research Site
Orange, California, United States, 92868
Status
N/A
Location
Research Site
Washington, District of Columbia, United States, 20007
Status
N/A
Location
Research Site
Gainesville, Florida, United States, 32610
Status
N/A
Location
Research Site
Lexington, Kentucky, United States, 40536
Status
N/A
Location
Research Site
Louisville, Kentucky, United States, 40202
Status
N/A
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