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Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Pregnancy Clinical Trial

Official title:
Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

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

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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