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Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Recruitingn/aAges any - anyFemaleAlexion Pharmaceuticals, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Ultomiris
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Where

7 sites
Research Site
Boston, United States
Research Site
Melbourne, Australia
Research Site
Paris, France
Research Site
Essen, Germany
Research Site
Rome, Italy
Research Site
Seoul, South Korea
Research Site
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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