Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT06312644
Status
Recruiting
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Conditions

  • Atypical Hemolytic Uremic Syndrome (aHUS)
  • Generalized Myasthenia Gravis (gMG)
  • Neuromyelitis Optica Spectrum Disorder (NMOSD)
  • Paroxysmal Nocturnal Hemoglobinuria (PNH)
  • Pregnancy
  • Ultomiris-exposed Pregnant/ Postpartum

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultomiris — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 16, 2024
Status verified
Apr 2026
Primary completion
Jul 11, 2034
Completion
Jul 11, 2034

Study Design

Enrollment
75 participants (estimated)

Primary Outcome Measure

Pregnancy Complications [ Time Frame: Up to 4 weeks post-delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteBostonMassachusetts02210
Sydney Willis
[email protected]
833-793-0563

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Research Site· Boston, MA

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