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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS41839 | Other Identifier | EU PAS |
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This is a worldwide safety surveillance study of pregnancy outcomes in women with hATTR-PN who may have been exposed or were not exposed to TEGSEDI prior to or during the pregnancy and of pediatric outcomes up to 1 year of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Cohort 1 will be pregnant patients who have been exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy. |
| |
| Cohort 2 | Cohort 2 will be pregnant patients who have hATTR-PN, who were not exposed to TEGSEDI or have not received TEGSEDI within the previous 25 weeks prior to conception. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inotersen | Drug | TEGSEDI injection, for subcutaneous use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Selected Pregnancy and Fetal/Neonatal Outcomes | Estimate the frequency of selected pregnancy and fetal/neonatal outcomes through 1 year of age in women who were exposed to at least 1 dose of TEGSEDI (Cohort 1) within 25 weeks prior to conception or during pregnancy, with the exposure window of interest for major congenital malformations being the first trimester, and in the unexposed cohort of pregnant women (Cohort 2) who have a diagnosis of hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN)
| 10 years or 12 months after the last live birth whichever is later |
| Frequency of Selected Pregnancy Complications | Estimate the frequency of selected pregnancy complications in women who were exposed to TEGSEDI (Cohort 1) within 25 weeks prior to conception or during pregnancy and in the unexposed cohort of pregnant women (Cohort 2) who have a diagnosis of hATTR-PN | 10 years or 12 months after the last live birth whichever is later |
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Inclusion Criteria:
TEGSEDI exposed patients (Cohort 1) meeting the following criteria will be eligible for study entry:
Unexposed patients (Cohort 2) meeting the following criteria will be eligible for study entry:
Exclusion Criteria:
None
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There will be 2 cohorts:
Cohort 1 will be pregnant patients who have been exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
Cohort 2 will be pregnant patients who have hATTR-PN, who were not exposed to TEGSEDI or have not received TEGSEDI within the previous 25 weeks prior to conception.
The exposed cohort will include pregnant patients from any country where TEGSEDI is marketed and/or clinical trials, post-market studies and registries are being conducted or expanded access programs are available.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ionis Pharmaceuticals | Contact | (844) 962-4787 | ionisNCT04270058study@clinicaltrialmedia.com |
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| ID | Term |
|---|---|
| C567782 | Amyloidosis, Hereditary, Transthyretin-Related |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000629536 | Inotersen |
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