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Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

RecruitingObservational study

Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Who can join

All ages · Women

Full eligibility criteria
Inclusion Criteria:

* 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 \[SmPC\])

Exclusion Criteria:

* 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

About the study

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.

What is being tested

Sponsor: Alexion Pharmaceuticals, Inc. · Participants: 75 · Started: Dec 16, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06312644

Locations in the U.S.

MassachusettsResearch Site, Boston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.