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Human Coagulation Factor Ix

Clinical trials involving Human Coagulation Factor Ix are studying how factor IX–containing products are used in urgent bleeding and surgery settings. The trials look at outcomes such as hemostatic effectiveness, reversal of anticoagulation, bleeding, and clotting events in adults at risk.

Table of Contents

Clinical trial overview

The trial data for Human Coagulation Factor Ix includes four Phase 3 interventional studies, which means the researchers are testing treatments in larger patient groups and looking at real clinical results.[1][2][3][4]

The studies cover different urgent and preventive settings, including major bleeding, urgent surgery or invasive procedures, blood clot prevention after joint replacement, and drug absorption after Roux-en-Y gastric bypass.[1][2][3][4]

Trials in major bleeding and anticoagulation reversal

One completed study, NCT04867837, enrolled 230 patients with acute major bleeding while receiving a direct oral anticoagulant, also called a DOAC, with a factor Xa inhibitor.[1]

This study compared two dose levels of OCTAPLEX and aimed to show better hemostatic effectiveness, meaning better control of bleeding, with the higher dose strategy in emergency reversal of the anticoagulant effect.[1]

Another Phase 3 study, 2022-503012-16-00, is authorised and includes patients treated with a factor Xa inhibitor who need an urgent intervention with a high risk of bleeding.[2]

In that study, the main question is whether TAK-330 can provide effective intraoperative hemostasis, which means good bleeding control during surgery or a procedure, compared with standard care using 4F-PCC.[2]

The study also uses blood test rules at screening, including specific anti-FXa levels, to identify patients who still have meaningful anticoagulant activity before the urgent procedure.[2]

Trials in clot prevention after hip or knee replacement

The DISTINCT trial, NCT06581965, is a large authorised Phase 3 study with 10,078 participants undergoing total hip or total knee replacement.[3]

This trial studies different thrombosis prophylaxis, which means blood clot prevention, based on each patient’s clot risk level rather than using the same approach for everyone.[3]

The study compares several options, including apixaban, rivaroxaban, dabigatran, dalteparin, enoxaparin, nadroparin, and Cofact, and it measures both venous thromboembolism and major bleeding in the first 3 months after surgery.[3]

Its brief summaries describe three goals: in low-risk patients, to see whether in-hospital prophylaxis only works as well as standard prophylaxis; in intermediate-risk patients, to measure the rate of symptomatic VTE; and in high-risk patients, to see whether intensified prophylaxis is more effective and still safe.[3]

Trial after Roux-en-Y gastric bypass

The WENDY study, 2024-519737-30-00, is an authorised Phase 3 trial in 30 patients with Roux-en-Y gastric bypass.[4]

This study looks at the difference in the pharmacokinetics of apixaban before and after surgery; pharmacokinetics means how the body absorbs and handles a drug.[4]

The main outcome is the area under the curve, or AUC, of anti-Xa levels at several time points from before surgery to up to 3 months after surgery.[4]

The trial is designed to understand whether surgery changes drug exposure over time in this patient group.[4]

Main outcomes measured in the trials

The trials measure different outcomes depending on the setting, but all focus on practical clinical questions.[1][2][3][4]

  • Hemostatic effectiveness: whether bleeding is controlled well enough to count as effective treatment.[1]

  • Intraoperative hemostatic efficacy: whether bleeding is controlled during surgery or an invasive procedure.[2]

  • Venous thromboembolism and major bleeding: whether clotting or serious bleeding happens after hip or knee replacement.[3]

  • Anti-Xa levels and AUC: blood test measures used to track anticoagulant activity and drug exposure over time.[2][4]

Who these trials are designed for

The studies focus on adults in urgent or high-risk situations rather than on healthy volunteers.[1][2][3][4]

  • Patients with acute major bleeding while using a factor Xa inhibitor, where fast bleeding control is needed.[1]

  • Patients who need urgent surgery or another invasive procedure while still under the effect of a factor Xa inhibitor.[2]

  • People recovering from total hip or total knee replacement, where the study compares clot prevention strategies across different clot risk levels.[3]

  • Patients after Roux-en-Y gastric bypass, where the study checks how surgery may change apixaban exposure.[4]

Trial ID Phase Condition studied Status Enrollment
NCT04867837 Phase 3 Acute major bleeding in patients receiving DOAC therapy with factor Xa inhibitor Completed 230
2022-503012-16-00 Phase 3 Patients on treatment with Factor Xa Inhibitor needing urgent intervention with high bleeding risk Authorised 436
NCT06581965 Phase 3 Venous thromboembolism after total hip or knee replacement Authorised 10078
2024-519737-30-00 Phase 3 Roux-en-Y gastric bypass Authorised 30

FAQ

  • What are the clinical trials with Human Coagulation Factor Ix studying? They are studying how factor IX–containing products work in urgent situations such as major bleeding, emergency reversal of anticoagulation, and prevention of blood clots after joint replacement surgery.
  • Who can take part in these trials? The target groups include adults with acute major bleeding on factor Xa inhibitor therapy, patients needing urgent surgery or invasive procedures while taking a factor Xa inhibitor, and people at different clot risk levels after hip or knee replacement.
  • What trial phases are listed? All of the listed studies are Phase 3 trials. This means they are testing the interventions in larger groups of patients and measuring how well they work in real clinical situations.
  • What outcomes are the trials measuring? The trials measure hemostatic effectiveness, intraoperative bleeding control, the number of venous thromboembolisms, major bleeding events, and anti-Xa levels after surgery. Anti-Xa levels help show how much factor Xa inhibitor activity is present in the blood.
  • Are these trials all in the same condition? No. Some focus on acute bleeding and urgent reversal of anticoagulation, while others focus on clot prevention after total hip or knee replacement or on drug absorption after gastric bypass surgery.

Ongoing Clinical Trials on Human Coagulation Factor Ix

  • Study on Venous Thromboembolism Prevention with Enoxaparin Sodium and Drug Combination for Patients Undergoing Total Hip or Knee Replacement

    Recruiting

    1 1 1 1
    Investigated drugs:
    The Netherlands

  • Study on TAK-330 for Reversing Anticoagulation in Patients on Factor Xa Inhibitors Needing Urgent Surgery

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +5

  • Study on the Effects of Apixaban Absorption in Patients Undergoing Roux-en-Y Gastric Bypass Surgery

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    The Netherlands

  • Study on the Effectiveness of Human Coagulation Factor IX and Drug Combination for Patients with Major Bleeding on Factor Xa Inhibitor Therapy

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Austria Croatia Germany Italy Poland Spain

Glossary

  • Phase 3: A later stage of clinical testing in larger patient groups, used to see how well a treatment works and to monitor results in real practice.
  • Interventional study: A trial where researchers give a treatment or compare treatments to study the effects.
  • Hemostatic effectiveness: How well a treatment stops bleeding or controls blood loss.
  • Major bleeding: Serious bleeding that needs urgent medical care.
  • Factor Xa inhibitor: A type of blood thinner that lowers the blood’s ability to clot.
  • Reversal of anticoagulation: Stopping or reducing the effect of a blood thinner when fast clotting control is needed.
  • Urgent intervention: A surgery or procedure that cannot be delayed.
  • Intraoperative hemostasis: Bleeding control during an operation or procedure.
  • Venous thromboembolism (VTE): A blood clot in a vein, which can include deep vein thrombosis or pulmonary embolism.
  • Anti-Xa level: A blood test result that helps show the amount of factor Xa inhibitor activity in the body.

References