drugset / Trial / NCT04557735

Study of Ravulizumab in Pediatric Participants With HSCT-TMA

NCT04557735

Phase 3 Completed 41 enrolled Alexion Pharmaceuticals, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-12-07
Primary completion
2024-11-26
Completion
2025-05-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Ravulizumab Monoclonal antibody Intravenous