RecruitingNCT06312644

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Sponsor

Alexion Pharmaceuticals, Inc.

Enrollment

75 participants

Start Date

Dec 16, 2024

Study Type

OBSERVATIONAL

Conditions

Pregnancy Ultomiris-exposed Pregnant/ Postpartum

Summary

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

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is tracking the safety of Ultomiris (ravulizumab) — a medication used for rare blood and kidney conditions — when taken during pregnancy. It collects information about both the mother's and baby's health outcomes to better understand any risks. **You may be eligible if...** - You are pregnant (or were recently pregnant) and have been exposed to Ultomiris at any point during the pregnancy - You have a diagnosed condition for which Ultomiris is approved (such as PNH, aHUS, or related disorders) - You are willing to provide your contact information and authorize sharing of relevant medical records - If you are a minor, a parent or guardian can provide consent on your behalf **You may NOT be eligible if...** - You have not been exposed to Ultomiris during a confirmed pregnancy - You are unwilling to allow access to relevant medical records Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUltomiris

Participants exposed to Ultomiris at any point during the 40 weeks prior to conception (LMP+14 days) or at any point during pregnancy or breastfeeding up to 52 weeks after birth.