Phase
Condition
Pregnancy
Anemia
Neuropathy
Treatment
Ultomiris
Ultomiris
Clinical Study ID
Female
Study Summary
Eligibility Criteria
Inclusion
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 ethicscommittee requirements) must be obtained prior to the participant's enrollment. Ifthe participant is a minor, consent must be obtained from the parent or legalguardian, 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 tothe study, upon request, if applicable to current local regulations.
Diagnosed with an indication for which Ultomiris is approved, based on HCP ormedical records.
Exposed to Ultomiris at any point during the defined exposure window based on HCP ormedical record documentation. (If exact exposure dates are unknown, the reportermust be able to specify or estimate trimester or timing of exposure [prior toconception as LMP+14 days, or during breastfeeding].)
Use of Ultomiris per local product information (i.e., United States PrescribingInformation [USPI] or summary of product characteristics [SmPC])
Exclusion
Exclusion Criteria:
- Participants who are unable to provide consent or assent (as locally appropriate) (e.g., diagnosed with severe psychiatric conditions or severe intellectualdisabilities) will be excluded from this study
Study Design
Study Description
Connect with a study center
North American call center (NACC)
Boston, Massachusetts 02210
United StatesActive - Recruiting
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