A Phase 2, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
This research study is investigating a new medication, RLYB212, for pregnant women who are at higher risk of having a baby affected by a rare, but serious, blood condition called Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT). FNAIT happens when the mother's immune system mistakenly attacks the baby's platelets, which are important for blood clotting. This can lead to the baby having very low platelet counts and potentially dangerous bleeding problems. The study will carefully check how the medicine behaves in the mother's body, including how long it stays there and at what levels, and will also closely monitor its safety for both the expectant mother and her developing baby. The aim is to find better ways to prevent this condition.
At a glance
What is this study about?
This study is about a condition called Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT). In simple terms, FNAIT occurs when a mother's immune system creates special proteins, called antibodies, that attack a specific type of protein (HPA-1a) on the baby's blood clotting cells, called platelets. These platelets are crucial for stopping bleeding. When these antibodies cross from the mother to the baby during pregnancy, they can destroy the baby's platelets, leading to very low platelet levels. This can cause severe bleeding in the baby, sometimes even before birth, in the brain or other organs.
Currently, treatment for FNAIT can be difficult. This study is testing a new medicine called RLYB212. The main goal is to understand how this medicine moves through and is processed by a pregnant woman's body (this is called 'pharmacokinetics'). Researchers will be carefully measuring how much of the medicine is in the blood, how long it stays there, and how it's cleared from the body. They also want to identify any side effects or problems that might occur in the mother or the baby.
By understanding how RLYB212 works and if it's safe, the hope is to find a better way to protect babies from FNAIT. This could help prevent the serious health problems that can arise from this condition. The study is in Phase 2, which means it’s an early stage of testing, focusing on safety and how the drug works in a small group of people.
Key takeaways
- This study is testing a new medicine (RLYB212) for pregnant women at risk of FNAIT.
- FNAIT is a rare condition that can cause serious bleeding in newborns.
- The study will check how the medicine works in the body and if it's safe for mothers and babies.
- Participation involves regular clinic visits, blood tests, and ultrasound monitoring.
- The goal is to find better ways to prevent FNAIT and its complications.
Who may be eligible?
To be considered for this study, you must be an adult woman, at least 18 years old. Importantly, you would need to be currently pregnant and known to be at a higher risk for this specific blood condition called FNAIT, specifically related to the HPA-1a type.
This means that either you have had a previous pregnancy where your baby was affected by FNAIT due to HPA-1a, or you have been identified as having the specific blood markers that put you at high risk for it.
There will be other detailed medical checks to make sure the study medicine is safe and appropriate for you and your baby. These checks would be explained fully by the study team.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you currently pregnant?
- Have you been told you are at higher risk for FNAIT caused by HPA-1a antibodies?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you choose to participate, you will receive the study medicine, RLYB212. This will involve regular visits to the clinic for check-ups. During these visits, the study team will take blood samples to measure how the medicine is working and to check your overall health. They will also perform physical examinations and check your vital signs like blood pressure and heart rate. You will also have regular ultrasounds to monitor your baby's health and development. There will be careful monitoring of any side effects you might experience. After your baby is born, there will be follow-up appointments for both you and your baby to check on your health and your baby's development for several weeks, normally up to about 4-6 weeks after birth.
Potential risks and benefits
Locations (4)
- —UnverifiedNetherlands
- —UnverifiedNorway
- —UnverifiedBelgium
- —UnverifiedSweden
Common questions
What is FNAIT?
FNAIT is a rare blood condition where a mother's immune system can attack her baby's platelets, leading to bleeding problems in the baby.
Is this medicine (RLYB212) already approved?
No, RLYB212 is an experimental medicine being tested in a study. It is not yet approved for general use.
Will my baby get this medicine directly?
The medicine is given to the mother, and the study is researching if it can protect the baby. The baby does not receive the medicine directly.
What kind of tests will be done?
You will have blood tests, physical exams, vital sign checks, ECGs (heart tracings), and ultrasounds to monitor your baby.
How long will I be in the study?
The study involves regular visits during your pregnancy and follow-up for you and your baby for about 4-6 weeks after the birth.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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