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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Complications | Pregnancy outcomes | 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 | 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 | In utero through 52 weeks of age after exposure to Ultomiris (in utero or via breastmilk) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. (Sponsor) | Contact | 1-855-752-2356 | clinicaltrials@alexion.com |
| Name | Affiliation | Role |
|---|---|---|
| Sydney Williams | North American Coordinating Center (NACC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Boston | Massachusetts | 02210 | United States |
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| Research Site | Not yet recruiting | Melbourne | Victoria | 3050 | Australia |
|
| Research Site | Recruiting | Paris | 75475 | France |
|
| Research Site | Recruiting | Essen | Norte-Westfalia | D-45147 | Germany |
|
| Research Site | Recruiting | Rome | 00168 | Italy |
|
| Research Site | Active, not recruiting | Seoul | South Korea |
| Research Site | Active, not recruiting | London | SE5 9NU | United Kingdom |
| ID | Term |
|---|---|
| D006457 | Hemoglobinuria, Paroxysmal |
| D065766 | Atypical Hemolytic Uremic Syndrome |
| D009157 | Myasthenia Gravis |
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D006463 | Hemolytic-Uremic Syndrome |
| D014511 | Uremia |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000629409 | ravulizumab |
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