In short
Clinical trials of Human Plasma Derived Antithrombin are studying its use in people with congenital antithrombin deficiency who are having surgery or giving birth. These trials aim to measure safety and effectiveness by looking at thrombotic and thromboembolic events. The main study is a Phase 3 trial.
Key points
- Clinical trials of Human Plasma Derived Antithrombin are focused on people with congenital antithrombin deficiency. The main study is a Phase 3 interventional trial in patients having surgery or delivery. Researchers are measuring whether clot-related events happen during treatment and up to 30 days after treatment starts. The trial has an enrollment of 46 people and is listed as authorised. The key endpoint is a composite of thrombotic events and thromboembolic events.
Clinical trial overview
The main study in the source data is NCT04918173, a Phase 3 interventional trial of Human Plasma Derived Antithrombin for patients with congenital antithrombin deficiency who are undergoing surgery or delivery.
The study title says it is looking at the efficacy of Atenativ in this patient group, and the brief summary says the main objective is to assess clot-related events during surgical procedures or childbirth.
Who the trial is for
The trial targets people with congenital antithrombin deficiency, which means the condition is present from birth.
It is focused on patients who are having surgical procedures or parturition, which is the medical word for giving birth.
This makes the study especially relevant for a specific high-risk group rather than for all patients with the condition.
Treatment and study design
The study is listed as an interventional trial, which means the researchers are giving a treatment and measuring what happens.
The intervention is Human Plasma Derived Antithrombin, listed in several country-specific product names for Atenativ, all given by intravenous infusion.
The source data does not describe a comparison group in the text provided, so the main focus here is on the treatment group being observed during surgery or delivery.
What the trial measures
The primary outcome is the incidence of a composite of thrombotic events and thromboembolic events.
In simple terms, the study counts clot-related problems, combining more than one type of event into one main result.
The outcome is measured under cover of Atenativ for surgical procedures or parturition, and it is tracked up to 30 days after treatment initiation.
Trial status and size
The study status is listed as Authorised.
The enrollment is 46, meaning 46 participants are planned or included in the study record provided.
Because only one trial is provided in the source data, the evidence base here is limited to this single Phase 3 study.