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Human Plasma Derived Antithrombin

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.

Table of contents

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.[1]

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.[1]

Who the trial is for

The trial targets people with congenital antithrombin deficiency, which means the condition is present from birth.[1]

It is focused on patients who are having surgical procedures or parturition, which is the medical word for giving birth.[1]

This makes the study especially relevant for a specific high-risk group rather than for all patients with the condition.[1]

Treatment and study design

The study is listed as an interventional trial, which means the researchers are giving a treatment and measuring what happens.[1]

The intervention is Human Plasma Derived Antithrombin, listed in several country-specific product names for Atenativ, all given by intravenous infusion.[1]

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.[1]

What the trial measures

The primary outcome is the incidence of a composite of thrombotic events and thromboembolic events.[1]

In simple terms, the study counts clot-related problems, combining more than one type of event into one main result.[1]

The outcome is measured under cover of Atenativ for surgical procedures or parturition, and it is tracked up to 30 days after treatment initiation.[1]

Trial status and size

The study status is listed as Authorised.[1]

The enrollment is 46, meaning 46 participants are planned or included in the study record provided.[1]

Because only one trial is provided in the source data, the evidence base here is limited to this single Phase 3 study.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04918173 Phase 3 Congenital antithrombin deficiency Authorised 46

FAQ

  • Who can take part in trials of Human Plasma Derived Antithrombin? The main trial includes patients with congenital antithrombin deficiency. It focuses on people who are undergoing surgery or delivery.
  • What is being studied in these trials? The trials are studying whether Human Plasma Derived Antithrombin can help during surgical procedures or childbirth. The main outcome is the number of thrombotic and thromboembolic events.
  • What phase is the main trial? The main study is a Phase 3 trial. This means it is a later-stage study that looks at how well the treatment works in a specific patient group.
  • What condition is the trial focused on? The trial is focused on congenital antithrombin deficiency. This is the condition listed in the trial data.
  • What result is the trial measuring? The primary outcome is the incidence of a composite of thrombotic events and thromboembolic events. In simple terms, the study counts clot-related problems after treatment starts, up to 30 days.

Ongoing Clinical Trials on Human Plasma Derived Antithrombin

  • Study on the Effectiveness of Atenativ for Patients with Congenital Antithrombin Deficiency Undergoing Surgery or Childbirth

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria Czechia France Germany Hungary Italy +2

Glossary

  • Congenital antithrombin deficiency: A condition present from birth. In the trial data, this is the disease being studied.
  • Surgery: An operation. The trial includes patients who need surgical procedures.
  • Delivery: Childbirth. The trial includes patients around the time of giving birth.
  • Phase 3: A later stage of clinical testing that studies how well a treatment works in a specific group of patients.
  • Interventional study: A study where patients receive a treatment or intervention that researchers want to test.
  • Enrollment: The number of people planned or included in a study.
  • Thrombotic events: Problems caused by blood clots forming in the body.
  • Thromboembolic events: Problems caused when a blood clot moves and blocks blood flow somewhere else.
  • Primary outcome: The main result the researchers want to measure.
  • Composite outcome: A main result that combines more than one type of event into one measure.
  • Intravenous infusion: Treatment given through a vein.

References