Trials / Recruiting
RecruitingNCT06312644
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 75 (estimated)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Ultomiris-exposed Pregnant/ Postpartum
- Pregnancy
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Atypical Hemolytic Uremic Syndrome (aHUS)
- Generalized Myasthenia Gravis (gMG)
- Neuromyelitis Optica Spectrum Disorder (NMOSD)
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-12-16
- Primary completion
- 2034-07-11
- Completion
- 2034-07-11
- First posted
- 2024-03-15
- Last updated
- 2026-04-16
Locations
7 sites across 7 countries: United States, Australia, France, Germany, Italy, South Korea, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06312644. Inclusion in this directory is not an endorsement.