NCT04743804

Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombotic Microangiopathy

Interventions

Type	Name	Description
BIOLOGICAL	Ravulizumab	Body weight-based doses of ravulizumab will be administered intravenously as loading dose regimen followed by maintenance dosing every 8 weeks.
OTHER	Placebo	Matching placebo
OTHER	Best Supportive Care	Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol).

Timeline

• Start date: 2021-06-29
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2021-02-08
• Last updated: 2024-10-01
• Results posted: 2023-12-12

Locations

97 sites across 13 countries: United States, Belgium, Brazil, Canada, France, Germany, Italy, Japan, Netherlands, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study