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Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies
EU CTIS ID: 2023-504307-88-00
What this study is testing
To evaluate the superiority of nipocalimab compared with placebo in reducing the risk of severe FNAIT
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 18 (or the legal age of consent if above 18 years of agein local region) to 45 years at the time of informed consent.
- Pregnant and an estimated GA (based on ultrasound dating) from Week 13^0/7 to 18^6/7 at randomization.
- Has a history of ≥1 prior pregnancy with FNAIT (including neonatal platelet count <150×109/L), with none of them affected by fetal/neonatal ICH or severe hemorrhage based on medical records
- Current pregnancy with presence of maternal anti-HPA-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal DNA in maternal blood
- Health status considered stable by the investigator on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening
You likely can't join if
- Currently pregnant with multiple gestations (twins or more)
- History of severe preeclampsia in a previous pregnancy
- History of severe FGR (birth weight <3rd percentile for GA) in a previous pregnancy.
- History of myocardial infarction, unstable ischemic heart disease, or stroke
- Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the IB)
The study team makes the final eligibility decision.
Where it's taking place
- Singapore
- Switzerland
- United States
- Brazil
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore; Switzerland; United States; Brazil; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.