Table of Contents
- Overview of the trial program
- Who the study is for
- Trial phase and study design
- What the study measures
- Trial status and enrollment
- Important terms explained
Overview of the trial program
The available clinical trial studies Anti-(Integrin Beta-3) Human Monoclonal Antibody in pregnant women who are at higher risk for HPA-1a alloimmunization.[1] The trial is focused on fetal and neonatal alloimmune thrombocytopenia, a condition linked to Human Platelet Antigen 1 incompatibility.[1]
The study is interventional, which means participants received the study treatment as part of the research plan.[1] The brief summary says the main goals were to evaluate the pharmacokinetic profile during pregnancy and to assess maternal and fetal safety.[1]
Who the study is for
This trial includes pregnant women who are at higher risk for HPA-1a alloimmunization.[1] In simple terms, this means the study group is made up of women whose pregnancy may be affected by a blood type mismatch involving platelet markers.[1]
The condition being studied can affect the fetus or newborn, so the trial also pays attention to fetal safety with ultrasound monitoring.[1]
Trial phase and study design
The study is a Phase 2 trial.[1] Phase 2 trials usually look more closely at safety and early signs of how a treatment behaves in a specific group of patients.[1]
This was a completed study with 9 enrolled participants.[1] The treatment was given by subcutaneous injection, which means it was injected under the skin.[1]
What the study measures
The main outcomes were pharmacokinetic measures, which show how the treatment moves through the body over time.[1] These included half-life, maximum concentration, time to maximum concentration, apparent clearance, apparent volume of distribution, and area under the concentration-time curve.[1]
The study also measured safety outcomes, including the type, seriousness, and number of adverse events, or unwanted medical problems during the study.[1] Other safety checks included physical examination findings, vital signs, maternal laboratory values, ECG, and obstetric/fetal Doppler ultrasound.[1]
These measures help researchers understand both the mother’s response and any possible effects on the fetus during pregnancy.[1]
Trial status and enrollment
The trial with NCT06435845 is listed as Completed.[1] It enrolled 9 participants in total.[1]
Because only one trial is available in the source data, the current evidence base is small and focused on a narrow patient group.[1]
Important terms explained
Alloimmunization means the body makes antibodies against another person’s blood markers.[1] In pregnancy, this can matter when the mother and fetus have different platelet antigens.[1]
ECG stands for electrocardiogram, a test that records the heart’s electrical activity.[1] Doppler ultrasound is an ultrasound test that checks blood flow, including blood flow in pregnancy.[1]
Clearance is how fast the body removes a treatment, and volume of distribution is a way to describe how widely a treatment spreads in the body.[1] These are research terms used to understand the treatment’s behavior in the body.[1]
