In short
Clinical trials investigating "Human Coagulation Factor Ii" focus on real-world treatment questions such as bleeding control, anticoagulation reversal, and prevention of blood clots. The studies include patients needing urgent surgery, people having major bleeding, and patients undergoing hip or knee replacement or gastric bypass surgery. These trials mainly assess safety, effectiveness, and bleeding or clotting outcomes.
Key points
- Clinical trials investigating "Human Coagulation Factor Ii" are focused on urgent bleeding control, reversal of anticoagulation, and prevention of blood clots in specific patient groups. The studies are all Phase 3 trials, which means they test the treatments in larger patient groups. Some trials involve patients who need urgent surgery, while others include people with major bleeding, joint replacement surgery, or Roux-en-Y gastric bypass. The main outcomes include effective hemostasis, major bleeding, venous thromboembolism, and anti-Xa levels. Enrollment ranges from small studies with 30 participants to large studies with more than 10,000 participants.
Trial overview
All listed studies are Phase 3 trials, which are larger studies used to learn more about how well a treatment works and how safe it is in the target group.
The trials cover several clinical situations: urgent surgery in people taking factor Xa inhibitors, major bleeding during direct oral anticoagulant therapy, prevention of venous thromboembolism after hip or knee replacement, and apixaban absorption after Roux-en-Y gastric bypass.
Urgent reversal before surgery or invasive procedures
The trial with NCT 2022-503012-16-00 is an interventional Phase 3 study in patients on treatment with a Factor Xa inhibitor who need an urgent intervention with a high risk of bleeding.
This study compares TAK-330 with standard of care using 4-factor prothrombin complex concentrate, also called 4F-PCC, and it includes 436 participants.
The main goal is to evaluate intraoperative efficacy, which means how well bleeding is controlled during surgery or another invasive procedure.
The primary endpoint is intraoperative effective hemostasis, assessed at the end of surgery or the procedure by the principal investigator, surgeon, or a qualified surgical team member using a Four Point Intraoperative Hemostatic Efficacy Scale.
Treatment of acute major bleeding
The study NCT04867837 is a completed Phase 3 trial in patients with acute major bleeding while receiving direct oral anticoagulant therapy with a factor Xa inhibitor.
It enrolled 230 participants and tested OCTAPLEX at different doses for emergency reversal of the anticoagulant effect.
The main endpoint was the proportion of patients with haemostatic effectiveness, meaning whether the bleeding response was judged as excellent, good, poor, or none.
This trial focused on whether the higher dose was better than the lower dose for controlling bleeding in this urgent setting.
Clot prevention after joint replacement
The DISTINCT trial, NCT06581965, is a large Phase 3 study in people undergoing total hip or total knee replacement.
It includes 10,078 participants and compares different ways of preventing venous thromboembolism, which is a blood clot in a vein.
The study uses a national, multicenter, randomized, multi-arm, open-label design, which means it is done at several centers, people are placed into groups by chance, several treatments are compared, and both the researchers and participants know which treatment is being given.
The primary outcomes are the number of VTE events and the number of major bleeds during the first 3 months after surgery.
The brief summary shows that the study is split into risk groups: low risk, intermediate risk, and high risk, with different prophylaxis, or prevention, strategies for each group.
Drug absorption after gastric bypass
The WENDY study, NCT 2024-519737-30-00, is a Phase 3 prospective study in patients with Roux-en-Y gastric bypass.
It includes 30 participants and examines the effect of weight-loss surgery on the absorption of apixaban.
A prospective study follows people forward in time, which helps researchers compare measurements before and after surgery.
The primary 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.
In simple terms, this outcome helps show how much of the drug effect is present over time after the operation.
Main endpoints and what they mean
These trials measure different outcomes depending on the clinical setting, but they all focus on treatment effect and safety.
Hemostatic effectiveness means how well bleeding is stopped or controlled.
Venous thromboembolism outcomes measure whether blood clots develop after surgery.
Anti-Xa levels and AUC are laboratory measures used to understand how a drug behaves in the body and how strong its effect is over time.
Who the trials are for
The target populations are specific and vary by study, rather than covering all patients with the same disease.
- Patients taking a factor Xa inhibitor who need urgent surgery or another invasive procedure with a high bleeding risk.
- Patients having total hip or total knee replacement, with different clot-risk levels for prevention planning.
- Patients after Roux-en-Y gastric bypass, where drug absorption may change after surgery.
- Patients with acute major bleeding while on direct oral anticoagulant therapy with factor Xa inhibition.