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Набира участници NCT07541469

Rezdiffra Pregnancy and Lactation Registry

Заболявания: MASH - Metabolic Dysfunction-Associated Steatohepatitis

Спонсор: Madrigal Pharmaceuticals, Inc.

Налично на: БГ
Обобщение
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.
Описание
The purpose of the Rezdiffra™ Pregnancy and Lactation Registry is to create a worldwide information source, called a pregnancy registry. The registry will collect information about the safety of Rezdiffra™ (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.
Кой може да участва
Inclusion Criteria: 1. Female patients with NASH who have been exposed to at least 1 dose of resmetirom at any time during pregnancy (defined as having received resmetirom within 3 days prior to the date of conception and/or during pregnancy) and/or during lactation, and their infants (up to 12 months of age). 2. Patient or parent/legally authorized representative must be able to understand and provide consent through an Institutional Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent or assent form. Exclusion Criteria: NONE
Интервенции
Rezdiffra
DRUG
Места на провеждане 1
САЩ (1)
Madrigal Pharmaceuticals
West Conshohocken , Pennsylvania
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Само жени
Здрави доброволци
Не
Начална дата
04.03.2026
Крайна дата
08.04.2030
Регистрационен номер
NCT07541469
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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