In short
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.
Key points
- Clinical trials involving Human Coagulation Factor Ix are mainly Phase 3 studies. They look at urgent bleeding control, reversal of factor Xa inhibitor effects, and prevention of venous thromboembolism after hip or knee replacement. One study also looks at anti-Xa levels after Roux-en-Y gastric bypass. The target groups include adults with major bleeding, patients needing urgent surgery or procedures, and people with different clot risk levels after joint replacement. The main outcomes are bleeding control, clotting events, and blood test measures of anticoagulant activity.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The trial is designed to understand whether surgery changes drug exposure over time in this patient group.
Main outcomes measured in the trials
The trials measure different outcomes depending on the setting, but all focus on practical clinical questions.
- Hemostatic effectiveness: whether bleeding is controlled well enough to count as effective treatment.
- Intraoperative hemostatic efficacy: whether bleeding is controlled during surgery or an invasive procedure.
- Venous thromboembolism and major bleeding: whether clotting or serious bleeding happens after hip or knee replacement.
- Anti-Xa levels and AUC: blood test measures used to track anticoagulant activity and drug exposure over time.
Who these trials are designed for
The studies focus on adults in urgent or high-risk situations rather than on healthy volunteers.
- Patients with acute major bleeding while using a factor Xa inhibitor, where fast bleeding control is needed.
- Patients who need urgent surgery or another invasive procedure while still under the effect of a factor Xa inhibitor.
- People recovering from total hip or total knee replacement, where the study compares clot prevention strategies across different clot risk levels.
- Patients after Roux-en-Y gastric bypass, where the study checks how surgery may change apixaban exposure.