TAK-330 for Blood Clotting Disorders
Recruiting in Palo Alto (17 mi)
+58 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Takeda
Must be taking: Factor Xa inhibitors
Must not be taking: Procoagulants, Heparin
Disqualifiers: Recent MI, Stroke, Bleeding, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial compares two treatments for reversing blood thinners in patients needing urgent surgery. Both treatments help the blood clot normally again. One treatment is commonly used and has been studied extensively.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you are currently on a Factor Xa inhibitor like rivaroxaban, apixaban, or edoxaban. Some medications, like certain procoagulant drugs and heparin, are restricted before and during the trial.
What data supports the effectiveness of the treatment TAK-330 for blood clotting disorders?
Research shows that four-factor prothrombin complex concentrate (4F-PCC), which is part of TAK-330, is effective in managing severe bleeding in patients on warfarin and in various critical bleeding situations like trauma and liver failure. It has been proven to work better than plasma transfusions in these cases.
12345Is TAK-330 (4F-PCC) generally safe for humans?
Four-factor prothrombin complex concentrate (4F-PCC), also known as TAK-330, has been used safely in humans for reversing the effects of blood thinners like warfarin in cases of severe bleeding. However, its safety for other uses is not fully understood, and more research is needed to confirm its safety in different conditions.
12467How is the drug TAK-330 different from other treatments for blood clotting disorders?
TAK-330 is unique because it is a four-factor prothrombin complex concentrate (4F-PCC) that contains four essential blood clotting factors, making it effective for urgent reversal of blood thinners like warfarin. Unlike traditional plasma transfusions, 4F-PCC provides a more targeted and rapid response in managing critical bleeding situations.
12347Eligibility Criteria
Adults on oral Factor Xa inhibitors needing urgent surgery with high bleeding risk can join. They must have a negative pregnancy test if applicable, and either took their last dose of the inhibitor within 15 hours or show elevated anti-FXa levels. Excluded are those with certain clotting/bleeding disorders, severe organ failure, recent use of heparin or other trials, breastfeeding women, imminent death prognosis, recent major cardiovascular events or active major bleeding.Inclusion Criteria
I need urgent surgery and have a high bleeding risk due to recent Factor Xa inhibitor use.
Participant or legally authorized representative willing to sign e-consent/written informed consent form
I am 18 years old or older.
+2 more
Exclusion Criteria
I am being treated with PROTHROMPLEX TOTAL as standard care.
You have a history of IgA deficiency with allergic reactions and antibodies to IgA.
I haven't had a stroke, heart attack, severe blood clotting issues, or been hospitalized for severe COVID-19 in the last 3 months.
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive TAK-330 or SOC 4F-PCC prior to surgery for anticoagulation reversal
1 day
1 visit (in-person, hospitalization)
Surgery/Invasive Procedure
Participants undergo urgent surgery or invasive procedure with monitoring for hemostasis
1 day
1 visit (in-person, hospitalization)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including telehealth/phone call follow-up
30 days
1 visit (telehealth/phone call)
Participant Groups
The trial is testing TAK-330 against standard treatment (4F-PCC) for reversing anticoagulation from Factor Xa inhibitors in patients requiring urgent surgery. Participants will be randomly assigned to one of these treatments before their procedure and followed up via telehealth after 30 days.
2Treatment groups
Experimental Treatment
Active Control
Group I: TAK-330 25 IU/kgExperimental Treatment1 Intervention
Participants will receive TAK-330, 25 international unit per kilogram (IU/kg) single intravenous infusion on Day 1 (prior to surgery) as an initial dose and an additional dose of 25 IU/kg TAK-330 can be administered during the surgery if deemed necessary by the surgeon. The total dose of TAK-330 administered to the participant should not exceed 50 IU/kg or 5,000 IU, whichever is smaller.
Group II: SOC 4F-PCCActive Control1 Intervention
Participants will receive 4F-PCC (excluding Prothromplex Total and activated 4F-PCC) as standard of care (SOC) on Day 1 (prior to surgery). The dose and infusion speed of the SOC 4F-PCC will be based on local institutional protocols. An additional dose of SOC 4F-PCC not exceeding total dose of 50 IU/kg or 5,000 IU, whichever is smaller can be given during the surgery if required.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Harbor-UCLA Medical CenterTorrance, CA
University of California Davis Health SystemSacramento, CA
MedStar Washington Hospital Center - Washington Cancer Institute (WCI)Washington, United States
University of FloridaGainesville, FL
More Trial Locations
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Who Is Running the Clinical Trial?
TakedaLead Sponsor
Takeda Development Center Americas, Inc.Industry Sponsor
References
Clinical utilization of four-factor prothrombin complex concentrate: a retrospective single center study. [2023]Four-factor prothrombin complex concentrate (4F-PCC) was approved by the US Food and Drug Administration in 2013 for management of severely bleeding patients on warfarin therapy. We describe use of 4F-PCC at a large, suburban academic center.
Roles of Four-Factor Prothrombin Complex Concentrate in the Management of Critical Bleeding. [2022]Four-factor prothrombin complex concentrate (4F-PCC) is the term used to describe a pathogen-reduced, lyophilized concentrate that contains therapeutic amounts of at least 4 coagulation factors: Factor II (FII), Factor VII (FVII), Factor IX (FIX), and Factor X (FX). 4F-PCC has proven to be an effective hemostatic agent compared to plasma transfusion in several prospective randomized trials in acute warfarin reversal. In recent years, 4F-PCC has been used in various acquired coagulopathies including post-cardiopulmonary bypass bleeding, trauma-induced coagulopathy, coagulopathy in liver failure, and major bleeding due to anti-FXa (anti-Xa) inhibitors (eg, rivaroxaban and apixaban). As transfusion of frozen plasma (FP) has not been found efficacious in the above critical bleeding scenarios, there is increasing interest in expanding the use of 4F-PCC. However, efficacy, safety, and clinical implications of expanded use of 4F-PCC have not been fully elucidated. Prothrombin time and international normalized ratio are commonly used to assess dose effects of 4F-PCC. Prothrombin time/international normalized ratio are standardly use for warfarin titration, but they are not suited for real-time monitoring of complex coagulopathies. Optimal dosing of 4F-PCC outside of the current approved use for vitamin K antagonist reversal is yet to be determined. In this review, we will discuss the use of 4F-PCC in four critical bleeding settings: cardiac surgery, major trauma, end-stage liver disease, and oral anti-Xa reversal. We will discuss recent studies in each area to explore the dosing, efficacy, and safety of 4F-PCC.
Four-factor prothrombin complex concentrates in paediatric patients - a retrospective case series. [2018]Four-factor prothrombin complex concentrates (PCCs) are human plasma-derived products containing coagulation factors II, VII, IX and X as well as proteins C and S. They are licensed in many countries for treatment of bleeding or urgent periprocedural prophylaxis in patients with acquired deficiency of prothrombin complex coagulation factors, typically in the setting of vitamin K antagonist (VKA) usage. Efficacy and safety have been established in the adult population, but there is little information in the literature regarding their use for these indications in the paediatric population. We report on our institution's experience with these products in paediatric patients over a five-year period.
Comparison of Hemostatic Outcomes in Patients Receiving Fixed-Dose vs. Weight-Based 4-Factor Prothrombin Complex Concentrate. [2022]Four-factor prothrombin complex concentrate (4F-PCC) is a blood coagulation product indicated for urgent reversal of warfarin. Currently there are no studies using 4F-PCC as a fixed dose to achieve hemostasis with warfarin as well as direct factor Xa inhibitors.
Use of four-factor prothrombin complex concentrate (4F-PCC) for management of bleeding not associated with therapeutic anticoagulant use. [2023]Four-factor prothrombin complex concentrate (4F-PCC) may be an option for patients with bleeding unrelated to therapeutic anticoagulation to help with bleeding cessation and reduce blood component requirements.
Four-factor prothrombin complex concentrate for life-threatening bleeds or emergent surgery: A retrospective evaluation. [2022]Previous trials investigating usage of four-factor prothrombin complex concentrate (4F-PCC) excluded patients with various thrombotic risk factors. The objective of this study was to evaluate the safety and effectiveness of 4F-PCC in a real-world setting based on an institutional protocol that does not have strict exclusion criteria.
Coagulation Factor Plasma Levels Following Administration of a 4-Factor Prothrombin Complex Concentrate for Rapid Vitamin K Antagonist Reversal in Japanese Patients. [2022]Four-factor prothrombin complex concentrates (4F-PCCs) have been approved for urgent vitamin K antagonist reversal in Western countries for many years. Ethnicity and genetic variations between populations may influence the pharmacokinetic profile of 4F-PCC treatments.