Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Start Date
12/16/2024
Completion Date
7/11/2034
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.
Detailed 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.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Ultomiris
Conditions
Locations
Research Site
Boston, Massachusetts 02210
United States
Research Site
Melbourne, Victoria 3050
Australia
Research Site
Paris, 75475
France
Research Site
Essen, Norte-Westfalia D-45147
Germany
Research Site
Rome, 00168
Italy
Research Site
Seoul,
South Korea
Research Site
London, SE5 9NU
United Kingdom