For Healthcare Professionals

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified).
  2. 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).
  3. Willing to provide contact information for the participant.
  4. Willing to authorize HCP(s) to release maternal and infant medical information to the study, upon request, if applicable to current local regulations.
  5. Diagnosed with an indication for which Ultomiris is approved, based on HCP or medical records.
  6. 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].)
  7. 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


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-855-752-2356Email iconEmail Study Center

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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