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To evaluate pregnancy and clinical outcomes in women with NASH and their infants after exposure to Rezdiffra at any time during pregnancy and/or lactation.
The purpose of the Rezdiffraâ„¢ Pregnancy and Lactation Registry is to create a worldwide information source, called a pregnancy registry. The registry will collect information about the safety of Rezdiffraâ„¢ (resmetirom), an approved medication, during pregnancy and/or while breastfeeding. This will help doctors and other healthcare providers learn more about its effect on pregnant and breastfeeding women and their infant after delivery up to 12 months of age.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezdiffra | Drug | Exposure to at least one dose of Resmetirom. |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy and Infant Outcomes Among Women Exposed to Rezdiffra During Pregnancy and/or Lactation | To evaluate pregnancy and infant outcomes among women with NASH exposed to Rezdiffra during pregnancy and/or lactation, including pregnancy outcomes, congenital malformations, and infant growth, development, and safety outcomes. | From enrollment through pregnancy and up to 12 months of infant age (participant observational period up to approximately 21 months) |
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Inclusion Criteria:
Exclusion Criteria:
NONE
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The registry will allow healthcare providers (HCPs) to enroll eligible patients and will also allow eligible patients to self-enroll. The registry is voluntary.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madrigal Pharmaceuticals | Contact | 800-905-0324 | MHGSafety@iconplc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madrigal Pharmaceuticals | Recruiting | West Conshohocken | Pennsylvania | 19428 | United States |
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| Label | URL |
|---|---|
| The Rezdiffra Pregnancy and Lactation Registry | View source |
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