Neonatal alloimmune thrombocytopenia – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 12 Jun 2026 11:13:21 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Neonatal alloimmune thrombocytopenia – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study of Nipocalimab or IVIG for Pregnant Women at Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) https://clinicaltrials.eu/trial/study-of-nipocalimab-or-ivig-for-pregnant-women-at-risk-of-fetal-and-neonatal-alloimmune-thrombocytopenia-fnait/ Wed, 29 Apr 2026 15:02:04 +0000 https://clinicaltrials.eu/trial/study-of-nipocalimab-or-ivig-for-pregnant-women-at-risk-of-fetal-and-neonatal-alloimmune-thrombocytopenia-fnait/ This clinical trial is focused on studying a condition known as Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT). This is a rare condition that can occur during pregnancy, where the mother’s immune system mistakenly attacks the baby’s platelets, which are cells that help with blood clotting. The study will explore the effectiveness of two treatments: nipocalimab, which is a type of protein-based medication given through an injection, and human normal immunoglobulin (IV), also known as IVIG, which is a blood-derived product also administered through an injection.

The purpose of the study is to assess how well these treatments work in reducing the risk of severe FNAIT. Participants in the study will be randomly assigned to receive either nipocalimab or IVIG. The study will be conducted over a period of time, with regular monitoring to ensure the safety and health of both the mother and the baby. The treatment period for nipocalimab is up to 29 weeks, while for IVIG, it is up to 30 weeks.

Throughout the study, participants will receive regular check-ups and monitoring to track the health of the fetus and the mother. The study aims to determine if these treatments can help prevent severe bleeding or low platelet counts in the baby, both before and shortly after birth. This research is important for finding better ways to manage and treat FNAIT, potentially improving outcomes for affected pregnancies.

]]> Study on the Safety and Effects of RLYB212 in Pregnant Women at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-rlyb212-in-pregnant-women-at-risk-for-fetal-and-neonatal-alloimmune-thrombocytopenia/ Wed, 29 Apr 2026 14:58:48 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-rlyb212-in-pregnant-women-at-risk-for-fetal-and-neonatal-alloimmune-thrombocytopenia/ This clinical trial is focused on studying a condition known as Fetal and Neonatal Alloimmune Thrombocytopenia, which occurs due to incompatibility between the mother’s and baby’s platelets, specifically involving a protein called Human Platelet Antigen 1. The study is investigating a treatment called RLYB212, which is a type of medication known as a human monoclonal antibody. This medication is designed to target a specific protein in the body called integrin beta-3, and it is administered as a solution through a subcutaneous injection, meaning it is injected under the skin.

The purpose of this study is to understand how RLYB212 behaves in the body during pregnancy and to ensure it is safe for both the mother and the baby. Pregnant women who are at a higher risk for this condition will receive the medication multiple times during their pregnancy. The study will monitor how the medication is processed in the body and will check for any side effects in both the mother and the baby. This includes regular physical examinations, checking vital signs, and using ultrasound to monitor the baby’s health.

The study will also look at the presence of the medication in the baby’s blood at birth and will track the health and development of the baby for a few weeks after birth. Additionally, researchers will observe if the mother develops any antibodies against the medication, which could affect its effectiveness. The study aims to provide valuable information on the safety and effectiveness of RLYB212 for preventing complications related to Fetal and Neonatal Alloimmune Thrombocytopenia during pregnancy.

]]> Study on Nipocalimab for Reducing Risk of Fetal and Neonatal Alloimmune Thrombocytopenia in At-risk Pregnancies https://clinicaltrials.eu/trial/study-on-nipocalimab-for-reducing-risk-of-fetal-and-neonatal-alloimmune-thrombocytopenia-in-at-risk-pregnancies/ Wed, 29 Apr 2026 14:25:19 +0000 https://clinicaltrials.eu/trial/study-on-nipocalimab-for-reducing-risk-of-fetal-and-neonatal-alloimmune-thrombocytopenia-in-at-risk-pregnancies/ This clinical trial is focused on studying a condition known as Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), which can occur during pregnancy. FNAIT is a rare condition where the mother’s immune system mistakenly attacks the baby’s platelets, which are small blood cells that help with clotting. This can lead to low platelet counts in the baby, increasing the risk of bleeding. The study is testing a treatment called nipocalimab, which is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein. Nipocalimab is being compared to a placebo to see if it can reduce the risk of severe FNAIT in pregnancies that are considered at risk.

The purpose of the study is to evaluate whether nipocalimab is more effective than a placebo in reducing the risk of severe FNAIT. Participants in the study will receive either nipocalimab or a placebo, and the study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. The study will follow the participants throughout their pregnancy and monitor the health of the baby up to the first week after birth. This will help determine if nipocalimab can safely and effectively reduce the risk of complications associated with FNAIT.

Throughout the study, the health of both the mother and the baby will be closely monitored. This includes regular check-ups and assessments to ensure the safety and well-being of both. The study aims to provide valuable information on the potential benefits of nipocalimab in managing FNAIT and improving outcomes for at-risk pregnancies. Participants will be contributing to important research that could lead to better treatment options for this condition in the future.

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