Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Study Identifier:
D9289C00007
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
Recruiting
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: Ultomiris
Date
Dec 2024 - Oct 2034
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female
Age: N/A - N/A
Requirements Information
Sex
Female
Age
N/A - N/A
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: Ultomiris
Date
Dec 2024 - Oct 2034
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female
Age: N/A - N/A years
Requirements Information
Protocol 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.
Trial Locations
Location
Status
Location
North American call center (NACC)
Boston, Massachusetts, United States, 02210
Status
Recruiting