RecruitingOBSERVATIONAL

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

This study aims to understand how Ultomiris, a medicine, affects pregnant people and their babies. Researchers are collecting information on what happens during pregnancy, at birth, and up to one year after the baby is born, if the mother has used Ultomiris. This includes looking at any health issues for the mother or the baby. The study also gathers information on babies exposed to Ultomiris through breast milk. It's a way to monitor the safety of this medicine for those who need it and become pregnant or are breastfeeding, helping us learn more about its use in these situations.

At a glance

Status

Recruiting

Sponsor

Alexion Pharmaceuticals, Inc.

Enrolment target

Start

16 Dec 2024

Estimated completion

11 Jul 2034

Ultomiris-exposed Pregnant/ Postpartum Pregnancy Paroxysmal Nocturnal Hemoglobinuria (PNH)Atypical Hemolytic Uremic Syndrome (aHUS)Generalized Myasthenia Gravis (gMG)Neuromyelitis Optica Spectrum Disorder (NMOSD)

What is this study about?

This study is all about understanding the safety of a medicine called Ultomiris for people who are pregnant or breastfeeding. Doctors already know that Ultomiris is used to treat certain conditions like PNH, aHUS, gMG, and NMOSD, which are serious health problems.

The main goal is to carefully watch and record what happens to pregnant people who have taken Ultomiris. This includes looking at their health during pregnancy and any complications that might arise. It also involves closely checking the health of their babies, right from when they are in the womb, during birth, and then up until their first birthday. Researchers will also look at babies who might have been exposed to Ultomiris through breast milk.

By gathering all this information, the study hopes to get a clearer picture of how Ultomiris affects both mothers and babies. This will help doctors and patients make more informed decisions about using this important medicine during pregnancy and breastfeeding in the future.

Key takeaways

This study helps understand Ultomiris safety during pregnancy and breastfeeding.
It's for people who have already used Ultomiris.
Information on mothers and babies (up to 1 year) will be collected.
Your medical care won't change as part of the study.
You can stop participating at any time.

Who may be eligible?

This study is looking for women who are pregnant or have recently given birth and have taken the medicine Ultomiris. You need to have a confirmed pregnancy, either now or in the past, and have taken Ultomiris for one of the conditions it’s approved to treat.

To join, you or your legal guardian (if you're under 18) must be willing to give your permission and allow medical information about you and your baby to be shared with the study team. This helps everyone understand the effects of the medicine.

However, if you're unable to understand or give consent due to certain medical conditions, you won't be able to participate. This is to make sure everyone involved can fully understand and agree to what the study involves.

Quick self-check

Are you currently pregnant or have you recently given birth?
Have you taken Ultomiris either during pregnancy or when breastfeeding?
Were you taking Ultomiris for a condition it's approved to treat?
Are you able to give your permission (consent) for your medical information to be used?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it means that information about your pregnancy, your health, and your baby's health will be collected. This information will come from your medical records and possibly from talking to you or your healthcare team. The study will look at details about when you took Ultomiris, your pregnancy journey, the birth, and your baby's development up to their first birthday. This is an 'observational' study, which means you won't be given any new medicine or asked to change your current treatment for the study. Instead, researchers will simply gather existing information about what happened. There are no extra doctor's visits or medical procedures required specifically for this study. The total duration of data collection for each person will cover their pregnancy and their child’s first year of life.

Potential risks and benefits

The main benefit of taking part in this study is helping researchers learn more about how Ultomiris affects pregnancy and babies. This knowledge can improve care for other pregnant individuals in the future. As an observational study, you won't be given new medicines or treatments, so there are no direct medical risks from participating. However, your medical information will be shared with the study team, though steps are taken to protect your privacy. You are always free to leave the study at any time without affecting your medical care.

Locations (7)

Research Site
Boston, United States· Recruiting
Research Site
Melbourne, Australia· Not yet recruiting
Research Site
Paris, France· Recruiting
Research Site
Essen, Germany· Recruiting
Research Site
Rome, Italy· Recruiting
Research Site
Seoul, South Korea· Active not recruiting
Research Site
London, United Kingdom· Active not recruiting

Common questions

What is Ultomiris used for?

Ultomiris is a medicine used to treat serious conditions like Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), Generalized Myasthenia Gravis (gMG), and Neuromyelitis Optica Spectrum Disorder (NMOSD).

Do I have to take Ultomiris if I join this study?

No, this study is for people who have already taken Ultomiris. You will not be given new medicine or asked to change your existing treatment for the study.

What information will the study collect about me and my baby?

The study will collect information about your health during pregnancy, the outcome of your pregnancy, your baby's health at birth, and their development up to one year old, especially if you used Ultomiris.

How will my personal information be kept private?

The study team will take steps to protect your privacy when collecting and using your health information. They will follow strict rules to keep your details confidential.

Can I stop being part of the study once I start?

Yes, you can absolutely choose to leave the study at any time. This will not affect the medical care you receive for yourself or your baby.

How to find out more

Alexion Pharmaceuticals, Inc. (Sponsor)

clinicaltrials@alexion.com 1-855-752-2356 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.