Join a worldwide outreach campaign
The Maternal and Postnatal Outcomes Study (MOS) is a pregnancy registry to help healthcare providers and their patients learn about the safety of Elfabrio® for Fabry disease.
There are no study visits.
All interactions are by phone or online.
The purpose of the MOS pregnancy registry is to create a worldwide information source, called a pregnancy registry. Once established, the MOS registry will help doctors and other healthcare providers learn more about the effects of Elfabrio® (pegunigalsidase alfa-iwxj) on individuals with Fabry disease during pregnancy or while breastfeeding.
Being pregnant, having been pregnant, or breastfeeding while taking Elfabrio® (pegunigalsidase alfa-iwxj) for Fabry disease are the basic requirements for participating in the MOS pregnancy registry.
There are no study visits needed to be part of the MOS pregnancy registry. If you qualify, you will be asked to sign an informed consent form (like any other clinical study). 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 MOS website, providing information about your:
- Fabry disease and 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
Find out if you can participate by answering a few questions.
If you prequalify, (by answering the prescreener questions at the link above), you will be contacted by a member of the study team to answer a few more questions about your pregnancy, your Fabry disease, Elfabrio® (pegunigalsidase alfa-iwxj), and the health of the baby.
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.
Frequently asked questions (FAQs)
Taking part in this study is entirely voluntary. It is up to you to decide whether to take part in the study or not. If you decide to agree to take part, you will be asked to sign and date the informed consent form electronically in the registry web-based platform. Alternatively, you can also provide your verbal consent to participate in the study. You will receive a confirmation e-mail 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 course of the study will be kept strictly confidential.
By signing the consent form and taking part in this study, you agree for the clinical research organization (CRO) and Study Center (if applicable) to collect and process your and your child’s personal information and agree for Chiesi Farmaceutici S.p.A., who is the Sponsor for this study, to use your and your child’s personal data for the study, i.e. to learn about the study drug (Elfabrio®), to help with study drug approval by health authorities, and to support future research and to improve science.
Please note that providing your and your child’s personal data is needed in order to verify if you can take part and to include you in the study. Refusal to give consent to process your and your child’s personal data will mean that you cannot join the study.
Elfabrio® (pegunigalsidase alfa-iwxj) is a medication approved for the treatment of Fabry disease. The MOS pregnancy registry will collect information about the safety of Elfabrio® during pregnancy and/or while breastfeeding. Knowing this information will help individuals in the future make informed decisions when they become pregnant so that treatment for Fabry disease can continue without harming the pregnancy or developing baby.
Participation in any pregnancy registry is completely voluntary. Your decision to participate—or not participate—in this registry 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 study. 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.
Every pregnancy registry must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and do not outweigh any potential benefits to the study 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.
Chiesi, the maker of Elfabrio® (pegunigalsidase alfa-iwxj), is responsible for conducting this pregnancy registry.
