Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorAlexion Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ultomiris

Treatment groups

No treatment groups listed

Sponsors and collaborators