Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Status Not yet recruiting

Clinical Trial Summary

The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.

Clinical Trial Description

This observational study will collect prospective and retrospective data in participants exposed to Ultomiris during pregnancy and/or breastfeeding to assess risk of maternal complications, adverse effects on the developing fetus, and adverse effects on the infant. ;

Study Design

Related Conditions & MeSH terms

Atypical Hemolytic Uremic Syndrome
Atypical Hemolytic Uremic Syndrome (aHUS)
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Hemolytic-Uremic Syndrome
Myasthenia Gravis
Neuromyelitis Optica
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Pregnancy

Clinical Trial Details

NCT number	NCT06312644
Study type	Observational [Patient Registry]
Source	Alexion Pharmaceuticals, Inc.
Contact	Alexion Pharmaceuticals, Inc. (Sponsor)
Phone	1-855-752-2356
Email	clinicaltrials@alexion.com
Status	Not yet recruiting
Phase
Start date	March 29, 2024
Completion date	October 21, 2033

View Details

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