An observational study in Ultomiris-exposed Pregnant/ Postpartum, Pregnancy and Paroxysmal Nocturnal Hemoglobinuria (PNH), sponsored by Alexion Pharmaceuticals, Inc.. Recruiting at 7 sites in 7 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Observational
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Among 35 studies in Hemoglobinuria, Paroxysmal by AstraZeneca — 3 open to participants now, 7 under way, 2 of them phase 3. Hemoglobinuria, Paroxysmal · AstraZeneca.
Among the 35 studies in Hemoglobinuria, Paroxysmal by AstraZeneca, this one is the 5th largest by planned enrollment of the 10 observational ones that give a count, is one of 2 that started in 2024, is one of 10 observational ones, and was the 29th registered.
191 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 49 are open to participants now.
Browse Hemoglobinuria, Paroxysmal studies →3 of the 35 studies in Hemoglobinuria, Paroxysmal by AstraZeneca are open now, in 8 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
Alexion Pharmaceuticals, Inc. · Sites in Canada, France, United Kingdom
Ages 12–17
By country, each count listing its studies:
Of the 30 Hemoglobinuria, Paroxysmal studies recruiting now, 14 (47%) set no upper age limit and 12 (40%) stop at 75 or younger; 12 take children under 18; 4 take healthy volunteers.
This study: female · no healthy volunteers.
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35 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 8 · Phase 3 12 · Phase 4 2
First in 2004; this study’s year is marked. 2 started in 2024.
This study's planned enrollment of 75 is below the median of 90 across 37 observational studies indexed under Hemoglobinuria, Paroxysmal.
Median enrollment 26 across the 23 interventional studies, 75 across the 10 observational. Of the 26 that completed or were terminated, 18 (69%) have results posted.
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This study is registered under Alexion Pharmaceuticals, Inc., one of the names counted as AstraZeneca. Under that name alone:
Alexion Pharmaceuticals, Inc. is the lead sponsor of 255 studies on the registry; 23 are open to participants now.
Of its 101 completed or terminated interventional studies of FDA-regulated products, 75 (74%) have results posted.
1 of the studies in Hemoglobinuria, Paroxysmal by AstraZeneca that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06449001Phase 3Alexion Pharmaceuticals, Inc.Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis | 2027-05-28 |
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Among the 35 studies in Hemoglobinuria, Paroxysmal by AstraZeneca, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Participants exposed to Ultomiris at any point up to 40 weeks prior to conception (Last Menstrual Period +14 days) through pregnancy and/or breastfeeding through the first 52 weeks of the infant's life.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: There is no interventional drug. Ultomiris treatment is an inclusion criterion.
Pregnancy Complications
Pregnancy outcomes
Time frame: Up to 4 weeks post-delivery
Maternal Complications
Maternal Complications may include pre-eclampsia, eclampsia, deep-vein thrombosis (DVT), pregnancy-induced hypertension, gestational diabetes, preterm labor, placenta previa, and postpartum hemorrhage
Time frame: Up to 4 weeks post-delivery
Fetal/Infant Outcomes
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
Time frame: In utero through 52 weeks of age after exposure to Ultomiris (in utero or via breastmilk)
Not enrolling at this site.
Not enrolling at this site.
Started Dec 2024 (actual). Primary completion is estimated for Jul 2034, 114 months after the start.
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Alexion Pharmaceuticals, Inc. →