Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
About the study
Who can take part
INCLUSION 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
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
Study Locations
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How to Apply
Study Details
Contition
Ultomiris-exposed Pregnant/ Postpartum,Pregnancy,Paroxysmal Nocturnal Hemoglobinuria (PNH),Atypical Hemolytic Uremic Syndrome (aHUS),Generalized Myasthenia Gravis (gMG),Neuromyelitis Optica Spectrum Disorder (NMOSD)
Participants Needed
75
Est. Completion Date
Nov 29, 2033
Treatment Type
OBSERVATIONAL
Sponsor
Alexion Pharmaceuticals, Inc.
ClinicalTrials.gov NCT Identifier
NCT06312644
Study Number
ALX-PG-501
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