Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Sponsor: Alexion Pharmaceuticals, Inc.
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.
Official title: Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
75
Start Date
2024-12-16
Completion Date
2034-07-11
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
Ultomiris
Participants exposed to Ultomiris at any point during the 40 weeks prior to conception (LMP+14 days) or at any point during pregnancy or breastfeeding up to 52 weeks after birth.
Locations (8)
Research Site
Boston, Massachusetts, United States
Research Site
Melbourne, Victoria, Australia
Research Site
Paris, France
Research Site
Essen, Norte-Westfalia, Germany
Research Site
Rome, Italy
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
London, United Kingdom