Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
75 participants
OBSERVATIONAL
2024-12-16
2034-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sydney Williams
Role: PRINCIPAL_INVESTIGATOR
North American Coordinating Center (NACC)
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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D9289C00007
Identifier Type: -
Identifier Source: org_study_id
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