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RECRUITING
NCT06312644

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Sponsor: Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Official title: Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

75

Start Date

2024-12-16

Completion Date

2034-07-11

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

DRUG

Ultomiris

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.

Locations (8)

Research Site

Boston, Massachusetts, United States

Research Site

Melbourne, Victoria, Australia

Research Site

Paris, France

Research Site

Essen, Norte-Westfalia, Germany

Research Site

Rome, Italy

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

London, United Kingdom