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The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patisiran | Pregnant women exposed to commercial patisiran-LNP (ONPATTRO) during the 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Major Congenital Malformations | Major congenital malformations will be classified according to the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) and Metropolitan Atlanta Congenital Defects Program (MACDP) classification systems. | From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Minor Congenital Malformations | Minor congenital malformations will be classified classified according to the EUROCAT and MACDP classification systems. | From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months) |
| Prevalence of Pregnancy Outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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Any woman exposed to patisiran-LNP 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alnylam Clinical Trial Information Line | Contact | 1-877-ALNYLAM | clinicaltrials@alnylam.com | |
| Alnylam Clinical Trial Information Line | Contact | 1-877-256-9526 | clinicaltrials@alnylam.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Recruiting | Iowa City | Iowa | 52242 | United States | |
| Clinical Trial Site |
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| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| D011115 | Polyneuropathies |
| D028227 | Amyloid Neuropathies, Familial |
| D028226 | Amyloidosis, Familial |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010523 | Peripheral Nervous System Diseases |
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Pregnancy outcomes are defined as live birth, spontaneous abortions, stillbirths, elective abortions, molar or pregnancy, ectopic pregnancy, preterm births, and maternal death. |
| From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months) |
| Prevalence of Other Adverse Fetal/Neonatal/Infant Outcomes | Other adverse fetal/neonatal/infant outcomes are defined as low birth weight, failure to thrive, small for gestational age, postnatal growth and development, neonatal, and perinatal, or infant death. | From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months) |
| Recruiting |
| Nantes |
| France |
| Clinical Trial Site | Recruiting | Münster | Germany |
| Clinical Trial Site | Recruiting | Pavia | Italy |
| Clinical Trial Site | Recruiting | Groningen | Netherlands |
| Clinical Trial Site | Recruiting | Lisbon | Portugal |
| Clinical Trial Site | Recruiting | Madrid | Spain |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D017772 | Amyloid Neuropathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008661 | Metabolism, Inborn Errors |