Safety of Ultomiris during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather data on pregnancy outcomes and maternal complications in women exposed to Ultomiris during pregnancy and breastfeeding. It will assess both maternal health and the effects on the developing fetus and infant through the first year of life. The study will collect both prospective and retrospective data to provide a comprehensive understanding of the risks associated with Ultomiris exposure in these populations.

Why it matters

Who can join: the full rules

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:

* 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

Where it's running

• Research Site
  Boston, Massachusetts, United States Recruiting
• Research Site
  Paris, France Recruiting
• Research Site
  Essen, Norte-Westfalia, Germany Recruiting
• Research Site
  Rome, Italy Recruiting
• Research Site
  Melbourne, Victoria, Australia Not yet recruiting
• Research Site
  Seoul, South Korea Active not recruiting

Study contacts

• Principal investigator: Sydney Williams — North American Coordinating Center (NACC)
• Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
• Email: clinicaltrials@alexion.com
• Phone: 1-855-752-2356

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.