Trial NCT06312644
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
- Phase
- Not given
- Sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- Ultomiris-exposed Pregnant/ Postpartum; Pregnancy; Paroxysmal Nocturnal Hemoglobinuria (PNH); Atypical Hemolytic Uremic Syndrome (aHUS); Generalized Myasthenia Gravis (gMG); Neuromyelitis Optica Spectrum Disorder (NMOSD)
- Ages
- Any age
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified).Pregnancy
* 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:
* 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
Restrictions found (1)
- PregnancyOutrightinclusionShow in the text
Recruiting in Massachusetts
- Research Site · Boston, Suffolk County