Actively Recruiting
Observational Study of Ultomiris (Ravulizumab) Safety in Pregnancy
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-16
75
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the safety of Ultomiris (Ravulizumab) when used during pregnancy and breastfeeding. It focuses on describing how often and what kinds of pregnancy complications and maternal health issues occur in participants exposed to Ultomiris. The study also looks at certain outcomes for the fetus, newborn, and infant up to one year old after exposure to Ultomiris either during pregnancy or through breastmilk. The study observes participants who have been exposed to Ultomiris at any time during the 40 weeks before conception, throughout pregnancy, or during breastfeeding up to 52 weeks after birth. It collects both past and ongoing data without introducing any new treatments, following participants to monitor health and development over time. Participants will provide medical information about their pregnancy and maternal health, as well as data about their infant's health from in utero through the first year after birth. Researchers will review pregnancy and maternal complications up to four weeks after delivery and track fetal and infant outcomes for up to 52 weeks after birth to understand the effects of Ultomiris exposure. Consent and medical record authorization are required for participation.
CONDITIONS
Brief 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 enrollment.
- Willing to provide contact information.
- Willing to authorize healthcare providers to release maternal and infant medical information to the study as allowed by local regulations.
- Diagnosed with a condition approved for Ultomiris treatment based on healthcare provider or medical records.
- Exposed to Ultomiris at any point during 40 weeks before conception, pregnancy, or breastfeeding up to 52 weeks after birth based on documentation or estimated timing.
- Use of Ultomiris according to local product information.
You will not qualify if you...
- Unable to provide consent or assent as locally appropriate (e.g., due to severe psychiatric conditions or severe intellectual disabilities).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - From conception through 52 weeks after birth
Participants who have been exposed to Ultomiris during pregnancy or breastfeeding are observed to assess maternal and infant health outcomes.
Regular visits scheduled based on participant and healthcare provider availability
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)
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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