Have you taken
Rezdiffra™ (resmetirom) while pregnant and/or breastfeeding?
If you took Rezdiffra™ (resmetirom) while pregnant or lactating, you may be eligible to participate in the Rezdiffra™ Pregnancy and Lactation Registry.
There are no study visits.
All interactions are by phone or online.
Please answer a few questions to see if you qualify.
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 individuals. By registering and providing information about pregnancy and breastfeeding outcomes, participants will help individuals in the future make informed decisions when they become pregnant so that taking Rezdiffra can continue without harming the pregnancy or developing baby.
Find out if you qualify by answering a few questions.
You may also call 1-800-905-0324 for more information.
- No study visits are involved; participate from the comfort of your home.
- Help doctors and other healthcare providers learn more about the effects of Rezdiffra™ (resmetirom) on individuals during pregnancy or while breastfeeding.
- You may receive financial compensation for your time spent as part of your participation in this registry.
You may be eligible if you took or are taking Rezdiffra™ (resmetirom) during pregnancy or while breastfeeding. Even patients who stopped taking the drug after as little as a single dose may still be eligible.
Find out if you can participate by answering a few questions.
There are many medications to treat medical conditions that continue to provide benefit to individuals while pregnant, but the effects of those medications on the pregnancy and developing baby are not fully known. A pregnancy registry is a type of research study designed to create a database (collection of information) that helps doctors and other healthcare providers better understand if a certain medication has any effect on the pregnancy or the developing baby.
Pregnancy registry studies collect information on the pregnancy and the baby’s health during the newborn period and while breastfeeding. The ultimate purpose of a pregnancy registry is to help other individuals with the same condition and their doctors know what to expect while taking a certain medicine during pregnancy and/or breastfeeding so that the condition can still be treated while pregnant/breastfeeding.
There are no study visits needed to be part of the Rezdiffra™ Pregnancy and Lactation Registry. If you prequalify (by answering the prescreener questions online), you will be contacted by a member of the registry team to answer a few more questions about your pregnancy and the health of the baby. If you qualify and decide to take part, you will be asked to consent to participate in the registry over the phone. You will receive a copy of the consent language in an email to keep for your records. Then, you will be given access to a web-based platform to take part in the registry and record your information each trimester during pregnancy, at the end of the pregnancy, and every three months until the baby turns 1 year. All you do is answer questions on the Rezdiffra™ Pregnancy and Lactation Registry website, providing information about your:
- Treatment history
- Pregnancy
- Problems that you may have during pregnancy
- Breastfeeding
- Baby’s date of birth
- Baby’s birth weight
- Baby’s health during the first year
Please go to the prescreener page to see if you qualify.
Or call 1-800-905-0324 for more information.
Frequently asked questions (FAQs)
Taking part in this registry is entirely voluntary. It is up to you to decide whether to take part in the registry or not. If you agree to take part, you will be asked to consent to participate in the registry over the phone. You will receive a copy of the consent language in an email to keep for your records.
You may change your mind at any time and stop participating without giving any reason even if you agreed earlier.
If you decide against taking part, you will not receive any penalties or result in any loss of benefits and your doctor will continue to treat you with the most appropriate therapy for your condition.
All information collected about you and your child during the Rezdiffra™ Pregnancy and Lactation Registry will be kept strictly confidential.
By consenting to take part in this registry, you agree for the clinical research organization (CRO) to collect and process your and your child’s personal information and agree for Madrigal Pharmaceuticals, Inc., who is the Sponsor for this registry, to use your and your child’s personal data for the registry, i.e., to learn about Rezdiffra™ (resmetirom) and to support future research.
Please note that providing your and your child’s personal data is needed to verify if you can take part and to include you in the registry. Refusal to give consent to process your and your child’s personal data will mean that you cannot join the registry.
Rezdiffra™ (resmetirom) is an approved medication. The Rezdiffra™ Pregnancy and Lactation Registry will collect information about the safety of Rezdiffra™ (resmetirom) during pregnancy and/or while breastfeeding. Knowing this information will potentially help individuals in the future make informed decisions when they become pregnant and are breastfeeding so that taking Rezdiffra can continue without harming the pregnancy or developing baby.
Participation in any pregnancy registry is completely voluntary. Your decision to participate or not will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in the registry, you may withdraw from the registry at any time.
You may receive financial compensation for your time spent as part of your participation in this registry. The specific amount and details of this compensation will be explained to you prior to your participation.
You’ll first be asked some general questions here that help us see whether you meet the basic requirements of the registry. If you do, you will be contacted to see if you fit the specific qualifications for the registry.
You may also call 1-800-905-0324 for more information.
Every pregnancy registry must be reviewed, and is continually monitored, by an ethics and/or regulatory review committee to ensure the risks are as low as possible and do not outweigh any potential benefits to the participant. As a volunteer, you have the right to discontinue your participation and leave the registry at any time, with no penalty or loss of benefits to which you are otherwise entitled.
Madrigal, the maker of Rezdiffra™ (resmetirom), is responsible for conducting this pregnancy registry.
