Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in the UK / NCT06312644
Recruiting Observational

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

NCT06312644 · tracked via the Priya Life Science UK tracker
Sponsor
Alexion Pharmaceuticals, Inc
Phase
Observational
Started
2024-12-16
Last updated
2026-04-16

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Ultomiris →

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified). * Participant informed consent (written or e-consent per local regulations or ethics committee requirements) must be obtained prior to the participant's enrollment. If the participant is a minor, consent must be obtained from the parent or legal guardian, with assent from the minor (as locally appropriate). * Willing to provide contact information for the participant. * Willing to authorize HCP(s) to release maternal and infant medical information to the study, upon request, if applicable to current local regulations. * Diagnosed with an indication for which Ultomiris is approved, based on HCP or medical records. * Exposed to Ultomiris at any point during the defined exposure window based on HCP or medical record documentation. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester or timing of exposure \[prior to conception as LMP+14 days, or during breastfeeding\].) * Use of Ultomiris per local product information (i.e., United States Prescribing Information \[USPI\] or summary of product characteristics \[SmPC\]) Exclusion Criteria: * Participants who are unable to provide consent or assent (as locally appropriate) (e.g., diagnosed with severe psychiatric conditions or severe intellectual disabilities) will be excluded from this study

Primary outcome measure(s)

  • Pregnancy Complications — Up to 4 weeks post-delivery
    Pregnancy outcomes
  • Maternal Complications — Up to 4 weeks post-delivery
    Maternal Complications may include pre-eclampsia, eclampsia, deep-vein thrombosis (DVT), pregnancy-induced hypertension, gestational diabetes, preterm labor, placenta previa, and postpartum hemorrhage
  • Fetal/Infant Outcomes — In utero through 52 weeks of age after exposure to Ultomiris (in utero or via breastmilk)
    Fetal (in Utero)/infant (for Live Born Births) may include major congenital malformation (MCMs), full-term birth, preterm birth, low birth weight, size for gestational age, neonatal death, perinatal death, infant death, serious and severe infections of infants, infant hospitalization, growth delays, and abnormal postnatal growth and development

Trial sites (7)

FacilityCityRegionStatus
Research Site Boston Massachusetts Recruiting
Research Site Melbourne Victoria Not Yet Recruiting
Research Site Paris France Recruiting
Research Site Essen Norte-Westfalia Recruiting
Research Site Rome Italy Recruiting
Research Site Seoul South Korea Active Not Recruiting
Research Site London United Kingdom Active Not Recruiting

More Alexion Pharmaceuticals, Inc. trials in the UK

Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism Active, not recruiting
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) Active, not recruiting
Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN) Recruiting
Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP Active, not recruiting
Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants Active, not recruiting

Other trials for the same condition

A First-in-Human Safety and Efficacy Study of ALN-CFB, a Small Interfering RNA (siRNA) Targeting Complement Factor B, in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria With Persistent Anemia on a C5 Inhibitor Recruiting
Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding Recruiting
Safety, Tolerability, PK and PD of ADX-038 in Healthy Participants and Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Recruiting
A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy Enrolling by invitation
Biobank Cycle Collection Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06312644 on ClinicalTrials.gov ↗ ← All trials in the UK