clinical trial · NCT06312644
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Alexion Pharmaceuticals, Inc.·—·recruiting·n = 75
Ultomiris-exposed Pregnant/ PostpartumPregnancyParoxysmal Nocturnal Hemoglobinuria (PNH)Atypical Hemolytic Uremic Syndrome (aHUS)Generalized Myasthenia Gravis (gMG)Neuromyelitis Optica Spectrum Disorder (NMOSD)Ultomiris
brief 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.
started
Dec 16, 2024
primary completion
Jul 11, 2034
completion
Jul 11, 2034
last updated
Apr 16, 2026
detailed description
This observational study will collect prospective and retrospective data in participants exposed to Ultomiris during pregnancy and/or breastfeeding to assess risk of maternal complications, adverse effects on the developing fetus, and adverse effects on the infant.
official title
Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol