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Antithrombin Iii Human

Clinical trials of Antithrombin Iii Human are studying its use in people with hemophilia A or B and in people with antithrombin deficiency. These trials mainly look at safety, efficacy, and outcomes during surgery, delivery, or cardiac surgery. The studies include adults and patients with inherited or acquired antithrombin problems.

Table of Contents

Trial overview

Three clinical trials in the source data investigate Antithrombin Iii Human in different patient groups and clinical settings.[1][2][3] All three are Phase 3 studies, which means they are larger trials that focus on how well a treatment works and continue to check safety.[1][2][3] The studies include one completed trial and two authorised trials.[1][2][3]

Hemophilia study

The completed trial with NCT ID 2023-508884-59-00 studied people with hemophilia A or hemophilia B, with or without inhibitory antibodies to factor VIII or IX.[1] Inhibitory antibodies are proteins that can make treatment less effective because they block the clotting factors used in care.[1] This study was an interventional Phase 3 trial with 281 participants.[1]

The brief summary says the trial aimed to characterize the long-term safety and tolerability of fitusiran.[1] The primary outcome was the number of participants with treatment-emergent adverse events, which means health problems that started or became worse after treatment began.[1] The intervention list also included Antithrombin III, along with several clotting factor treatments used in the study context.[1]

Congenital antithrombin deficiency study

The authorised trial NCT04918173 studied patients with congenital antithrombin deficiency who were undergoing surgery or delivery.[2] Congenital means the condition is present from birth.[2] This was a Phase 3 interventional study with 46 participants.[2]

The study objective was to assess the incidence of a combined outcome made up of thrombotic events and thromboembolic events during treatment with Atenativ for surgical procedures or childbirth, and up to 30 days after treatment started.[2] This endpoint looks at whether blood clots form or travel in the body during a high-risk period.[2]

Cardiac surgery and heparin resistance study

The authorised trial NCT06096116 studied adult patients with acquired antithrombin deficiency who had heparin resistance and were scheduled for cardiac surgery needing cardiopulmonary bypass.[3] Acquired means the condition develops later in life rather than being present from birth.[3] This was also a Phase 3 interventional study with 142 participants.[3]

The primary efficacy endpoint was the percentage of patients who did not need any further antithrombin-containing therapy, such as fresh frozen plasma or other antithrombin concentrates, to restore heparin responsiveness before bypass and to keep it during bypass.[3] In simple terms, the study asked whether treatment could help heparin work well enough during heart surgery without extra rescue treatment.[3]

Main outcomes and what they mean

The trials measure different outcomes depending on the patient group and the procedure being studied.[1][2][3] In the hemophilia study, the main outcome was safety, measured by treatment-emergent adverse events.[1] In the congenital deficiency study, the main outcome was clot-related events during surgery or delivery and for 30 days after treatment started.[2] In the cardiac surgery study, the main outcome was whether heparin responsiveness could be restored and maintained without extra antithrombin therapy.[3]

Who the trials are for

  • People with hemophilia A or B: one completed trial studied patients with these bleeding disorders, including those with inhibitory antibodies to factor VIII or IX.[1]

  • People with congenital antithrombin deficiency: one authorised trial focused on patients with this inherited condition during surgery or delivery.[2]

  • Adults with acquired antithrombin deficiency and heparin resistance: one authorised trial studied adults scheduled for cardiac surgery with cardiopulmonary bypass.[3]

Trial ID Phase Condition studied Status Enrollment
2023-508884-59-00 Phase 3 Hemophilia A or B Completed 281
NCT04918173 Phase 3 Congenital antithrombin deficiency Authorised 46
NCT06096116 Phase 3 Acquired antithrombin deficiency (Heparin resistance) Authorised 142

FAQ

  • What conditions are being studied in trials of Antithrombin Iii Human? The trials study hemophilia A or B, congenital antithrombin deficiency, and acquired antithrombin deficiency with heparin resistance. Some studies focus on surgery, delivery, or cardiac surgery with cardiopulmonary bypass.
  • Who can take part in these trials? The target groups include patients with hemophilia A or B, patients with congenital antithrombin deficiency, and adult patients with acquired antithrombin deficiency who are scheduled for cardiac surgery. One study also includes patients undergoing surgery or delivery.
  • What phases are the Antithrombin Iii Human trials? The trials listed are Phase 3 studies. Phase 3 trials are larger studies that test how well a treatment works and continue to monitor safety.
  • What are the trials trying to measure? The studies measure safety, treatment effect, and specific clinical outcomes. These include treatment-emergent adverse events, thrombotic and thromboembolic events, and whether extra antithrombin therapy is needed.
  • Are these trials completed? One trial is completed, while two trials are authorised. This means some studies have finished and others are still approved to move forward.

Ongoing Clinical Trials on Antithrombin Iii Human

  • Study on Antithrombin III Human for Patients with Heparin Resistance Undergoing Cardiac Surgery with Cardiopulmonary Bypass

    Recruiting

    3 1 1
    Investigated drugs:
    Austria Czechia France Lithuania Poland Romania +2

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

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Czechia France Germany Hungary Italy +2

  • Study of Long-term Safety and Efficacy of Fitusiran in Patients with Hemophilia A or B with or without Inhibitory Antibodies to Factor VIII or IX

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Denmark France Hungary Ireland Italy

Glossary

  • Hemophilia A: A bleeding disorder caused by low or missing factor VIII, which can make bleeding last longer than normal.
  • Hemophilia B: A bleeding disorder caused by low or missing factor IX, which can also lead to prolonged bleeding.
  • Congenital antithrombin deficiency: A condition present from birth where the body has too little antithrombin, a natural blood-clot control protein.
  • Acquired antithrombin deficiency: Low antithrombin that develops later in life, not from birth.
  • Heparin resistance: A situation where heparin does not work well enough to prevent clotting as expected.
  • Cardiopulmonary bypass: A machine-assisted way to keep blood moving and oxygenated during some heart surgeries.
  • Thrombotic event: A blood clot that forms inside a blood vessel and may block blood flow.
  • Thromboembolic event: A clot that forms and then travels to another place in the body, where it can cause blockage.
  • Placebo: A look-alike treatment with no active medicine, used for comparison in a trial.
  • Primary outcome: The main result a trial is designed to measure.
  • Treatment-emergent adverse events: Health problems that appear or get worse after treatment starts.

References