Study of Ravulizumab in Pediatric Participants With HSCT-TMA

Thrombotic Microangiopathy Clinical Trial

Official title:
A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants With Thrombotic Microangiopathy (TMA) After Hematopoietic Stem Cell Transplantation (HSCT)

Status Recruiting

Clinical Trial Summary

This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab administered by intravenous infusion to pediatric participants, from 1 month to < 18 years of age, with HSCT-TMA. The treatment period is 26 weeks, followed by a 26-week off-treatment follow-up period.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04557735
Study type	Interventional
Source	Alexion Pharmaceuticals, Inc.
Contact	Alexion Pharmaceuticals Inc.
Phone	855-752-2356
Email	clinicaltrials@alexion.com
Status	Recruiting
Phase	Phase 3
Start date	November 6, 2020
Completion date	June 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02604420` - Identification and Treatment of Thrombotic Microangiopathies in Allogeneic Stem Cell Transplants
Terminated	`NCT04743804` - Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger	Phase 3
Recruiting	`NCT04845022` - Incidence of Snakebite Associated Thrombotic Microangiopathy & Role of Peripheral Blood Smear as a Predictor of Clinical Outcome
Terminated	`NCT00593229` - International Registry and Biorepository for TMA(Thrombotic Microangiopathy)	N/A
Recruiting	`NCT05991245` - French National Cohort MATRIX "Renal and Systemic Thrombotic Microangiopathy"
Terminated	`NCT00726544` - Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic Microangiopathy	Phase 2
Recruiting	`NCT04543591` - Ravulizumab in Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplant	Phase 3
Available	`NCT02355782` - OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy	N/A