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