Clinical trials: Coagulation
Chronic Primary Immune Thrombocytopenia (ITP)
A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)
The purpose of this study is to evaluate the efficacy and safety of KIg 10 (Intravenous Immunoglobulin 10%) in adult patients with chronic primary ITP
- Trial name
- ITP (NCT07059000)
- Testing
- Kedrion IVIG 10%
- Where
- 28 sites in United States, Czechia and 6 more
- Volunteers
- 40 people
- Sponsor
- Kedrion S.p.A.
Haemophilia A (Moderate or Severe)
Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa
This is a multinational, prospective, open-label, roll-over study in patients with haemophilia A, ≥6 years of age, who have completed participation in any of the parental studies with efanesoctocog alfa; XTEND-ed study…
- Trial name
- LIBERTY (NCT06716814)
- Testing
- Efanesoctocog alfa
- Where
- 20 sites in Bulgaria, France and 5 more
- Volunteers
- 89 people
- Sponsor
- Swedish Orphan Biovitrum
Sepsis, Venous Thromboembolism
An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related
This is an observational study in which data already collected from people with venous thromboembolism (VTE) due to sepsis (blood poisoning) are studied.
- Conditions
- Sepsis, Venous Thromboembolism, Disseminated Intravascular Coagulation
- Trial name
- NCT06765681
- Testing
- Diagnosis of both VTE and sepsis
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- Bayer
Sepsis, Coagulopathy
A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
Researchers are looking for a better way to treat people who have sepsis induced coagulopathy. Sepsis happens when bacteria and their toxins spread in the blood, causing an infection.
- Trial name
- NCT06854640
- Testing
- BAY3389934
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 36 people
- Sponsor
- Bayer
Severe Hemophilia A
Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A
This Phase 1/2 study will be a dose escalation study in adults in 5 cohorts (named cohorts 1, 2, 3, 5 and 6), with the main purpose to assess the safety of subcutaneous injection of OCTA101 (a human-cl rhFVIII and recombinant…
- Trial name
- NCT04046848
- Testing
- OCTA101
- Where
- Bulgaria
- Volunteers
- 36 people
- Sponsor
- Octapharma
Blood Loss, Surgical, Coagulation Disorder
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
The goal of this clinical trial is to learn if reltodecacog alfa (VMX-C001) works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that…
- Trial name
- EQUILIBRIX-S (NCT07288489)
- Testing
- Reltodecacog alfa, Usual Pharmacological Care
- Where
- 77 sites in United States, Australia and 16 more
- Volunteers
- 800 people
- Sponsor
- VarmX B.V.
Acquired Fibrinogen Deficiency
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
This study is a phase 3, prospective, single center, randomized, open label, controlled, parallel arm, interventional study to investigate the efficacy and safety of CSL511, in participants undergoing cytoreductive surgery (CRS)…
- Trial name
- NCT06617897
- Testing
- CSL511 Fibrinogen concentrate (human), Cryoprecipitate
- Where
- United Kingdom
- Volunteers
- 90 people
- Sponsor
- CSL Behring
Hemophilia A
Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa
The rationale for this study is to further understand and describe the long-term prophylactic effectiveness of efanesoctocog alfa in preventing joint bleeds in a real-life setting.
- Trial name
- NCT06940830
- Testing
- Efanesoctocog alfa
- Where
- 31 sites in Croatia, Czechia and 6 more
- Volunteers
- 252 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia A
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
This is a national, multicenter, retrospective/prospective, observational study in Taiwan designed to assess effectiveness, safety, and usage of efanesoctocog alfa prophylaxis treatment in hemophilia A participants.
- Trial name
- PROTECT-ALT (NCT06684314)
- Testing
- Efanesoctocog alfa
- Where
- 10 sites in Taiwan
- Volunteers
- 79 people
- Sponsor
- Sanofi
Pediatric, Coagulation
Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients
This study will determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.
- Trial name
- NCT07447713
- Testing
- Quantra System
- Where
- 4 sites in United States, Switzerland
- Volunteers
- 240 people
- Sponsor
- HemoSonics LLC
Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk
Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
- Trial name
- NCT06429787
- Testing
- Balfaxar, Kcentra
- Where
- United States
- Volunteers
- 3,574 people
- Sponsor
- Octapharma
Coagulation Disorder
Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant
A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts: Part 1: Single dose of…
- Trial name
- NCT06372483
- Testing
- VMX-C001, Rivaroxaban 20 mg Oral Tablet, Apixaban 5 mg Oral Tablet
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- VarmX B.V.
Hemophilia A With Inhibitor, Hemophilia A With Anti Factor VIII
Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec in Hemophilia A With Active or Prior Inhibitors
This Phase I/II clinical study will evaluate the safety and efficacy of valoctocogene roxaparvovec in patients with severe haemophilia A and inhibitors to FVIII.
- Trial name
- GENEr8-INH (NCT04684940)
- Testing
- Valoctocogene roxaparvovec
- Where
- 9 sites in United States, Brazil and 5 more
- Volunteers
- 10 people
- Sponsor
- BioMarin Pharmaceutical
Hemophilia A, Severe
A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa
FREEDOM is a multicentre, open-label, single-arm, phase 3b study in Europe that aims to enrol approximately 90 previously treated severe haemophilia A patients aged ≥12 years, currently on prophylaxis.
- Trial name
- FREEDOM (NCT05817812)
- Testing
- Efanesoctocog alfa
- Where
- 30 sites in Austria, Croatia and 12 more
- Volunteers
- 93 people
- Sponsor
- Swedish Orphan Biovitrum
Acquired Factor X Deficiency
A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis
The purpose of this study is to evaluate the efficacy and safety of Coagadex in treating active bleeds and to manage peri-operative bleeding in participants with acquired factor X deficiency associated with AL amyloidosis.
- Trial name
- NCT06963216
- Testing
- Coagadex(R)
- Sponsor
- Kedrion S.p.A.
Hemophilia A
Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A
Sobi.BIVV001-003 is an open-label, 2-period, fixed sequence study for intra-participant comparison of the PK profiles of efanesoctocog alfa and the extended half-life rFVIII products damactocog alfa pegol or turoctocog alfa pegol…
- Trial name
- NCT06579144
- Testing
- Efanesoctocog alfa
- Where
- 7 sites in Bulgaria, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- Swedish Orphan Biovitrum
Coagulation Disorder
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in…
- Trial name
- NCT05156983
- Testing
- TAK-330, SOC 4F-PCC
- Where
- 64 sites in United States, Argentina and 13 more
- Volunteers
- 440 people
- Sponsor
- Takeda
Sepsis Associated Disseminated Intravascular Coagulation (DIC)
A Study to Assess the Safety and Effects of Different Doses of an Investigational Drug, BAY 3389934, in Healthy Japanese Volunteers.
This study is designed to evaluate a new investigational drug, BAY 3389934, in healthy Japanese volunteers. The primary purpose is to see how safe the drug is and how well it is tolerated by the body when given at different…
- Trial name
- NCT07176728
- Testing
- BAY 3389934
- Where
- 2 sites in Japan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bayer
Coagulation Disorder
Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin
A single centre, open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin (UFH) and of VMX-C001 alone on the efficacy of Low Molecular Weight Heparin (LMWH)…
- Trial name
- NCT06517563
- Testing
- VMX-C001, Rivaroxaban, UFH
- Where
- Netherlands
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- VarmX B.V.
Hemophilia A
Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A
This Phase III clinical study will evaluate the safety and effectiveness of valoctocogene roxaparvovec in Japanese patients with severe hemophilia A.
- Trial name
- GENEr8-JPN (NCT06224907)
- Testing
- Valoctocogene roxaparvovec
- Where
- 4 sites in Japan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- BioMarin Pharmaceutical