Actively Recruiting
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-16
75
Participants Needed
7
Research Sites
499 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified).
- Participant informed consent (written or e-consent per local regulations or ethics committee requirements) must be obtained prior to the participant's enrollment. If the participant is a minor, consent must be obtained from the parent or legal guardian, with assent from the minor (as locally appropriate).
- Willing to provide contact information for the participant.
- Willing to authorize HCP(s) to release maternal and infant medical information to the study, upon request, if applicable to current local regulations.
- Diagnosed with an indication for which Ultomiris is approved, based on HCP or medical records.
- Exposed to Ultomiris at any point during the defined exposure window based on HCP or medical record documentation. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester or timing of exposure [prior to conception as LMP+14 days, or during breastfeeding].)
- Use of Ultomiris per local product information (i.e., United States Prescribing Information [USPI] or summary of product characteristics [SmPC])
You will not qualify if you...
- Participants who are unable to provide consent or assent (as locally appropriate) (e.g., diagnosed with severe psychiatric conditions or severe intellectual disabilities) will be excluded from this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Research Site
Boston, Massachusetts, United States, 02210
Actively Recruiting
2
Research Site
Melbourne, Victoria, Australia, 3050
Not Yet Recruiting
3
Research Site
Paris, France, 75475
Actively Recruiting
4
Research Site
Essen, Norte-Westfalia, Germany, D-45147
Actively Recruiting
5
Research Site
Rome, Italy, 00168
Actively Recruiting
6
Research Site
Seoul, South Korea
Active, Not Recruiting
7
Research Site
London, United Kingdom, SE5 9NU
Active, Not Recruiting
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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