Clinical trials: Disorders, Blood Coagulation
Congenital Bleeding Disorder, Congenital FXIII Deficiency
Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency
This trial will be conducted in Asia, Europe and the United States of America (USA). The aim of this clinical trial is to investigate long-term safety of rFXIII when administered for prevention of bleeding episodes in children…
- Trial name
- mentor™5 (NCT01253811)
- Testing
- catridecacog
- Where
- 4 sites in United States, Israel and 1 more
- Volunteers
- 6 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A
Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A
The objective of this clinical study is to compare the pharmacokinetic parameters of 3000 IU Advate using one 3000 IU potency vial dissolved in 5 mL diluent with that of 3000 IU Advate using two vials of 1500 IU potency dissolved…
- Trial name
- NCT00916032
- Testing
- Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]
- Where
- 4 sites in Bulgaria, Russia
- Volunteers
- 29 people
- Sponsor
- Baxalta now part of Shire
Hemophilia A
Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and will demonstrate evidence of hemostatic…
- Trial name
- NCT01439971
- Testing
- PF-05280602
- Where
- 23 sites in United States, Belgium and 6 more
- Volunteers
- 29 people
- Sponsor
- Catalyst Biosciences
Immune Thrombocytopenia (ITP)
A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)
This is a Phase 2, open-label, randomized, multicenter study to assess the efficacy and safety of DZD8586 in patients with primary immune thrombocytopenia (ITP).
- Trial name
- NCT07294365
- Testing
- DZD8586 dose level 1, DZD8586 dose level 2, DZD8586 dose level 3
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Dizal Pharmaceuticals
Congenital Bleeding Disorder, Congenital FVII Deficiency
Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency
This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.
- Trial name
- NCT01312636
- Testing
- activated recombinant human factor VII
- Where
- Japan
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S
Heart Failure, Respiratory Insufficiency
A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in…
- Conditions
- Heart Failure, Respiratory Insufficiency, Stroke Acute, Infectious Diseases
- Trial name
- MARINER (NCT02111564)
- Testing
- Rivaroxaban, 10 mg, Rivaroxaban, 7.5 mg
- Where
- 593 sites in United States, Argentina and 35 more
- Volunteers
- 12,024 people
- Sponsor
- Janssen Research & Development, LLC
Cardiac Surgery
Quantra Determination of Coagulation Parameters in Arterial and Venous Blood
The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole blood coagulation analysis. This study compares Quantra measurements determined in arterial versus venous blood samples obtained from…
- Trial name
- NCT02978872
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- HemoSonics LLC
Severe Hemophilia A
Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A
The purpose of this study is to obtain additional data on the safety and efficacy of Wilate in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII concentrate who undergo prophylactic treatment with…
- Trial name
- NCT02954575
- Testing
- Wilate
- Where
- 7 sites in Bulgaria, Hungary and 3 more
- Volunteers
- 57 people
- Sponsor
- Octapharma
Hemophilia B
Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B
The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time.
- Trial name
- NCT01233440
- Testing
- Recombinant Coagulation Factor IX Albumin Fusion Protein, Plasma derived FIX [pdFIX]
- Where
- 20 sites in Austria, France and 4 more
- Volunteers
- 25 people
- Sponsor
- CSL Behring
Primary Immune Thrombocytopenia
A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia…
- Trial name
- myOpportunITy2 (NCT04224688)
- Testing
- Rozanolixizumab
- Where
- 29 sites in United States, Bulgaria and 9 more
- Volunteers
- 30 people
- Sponsor
- UCB Biopharma SRL
Autoimmune Thrombocytopenia
Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia
This is a single-arm, open-label，phase I clinical study to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia.
- Trial name
- NCT06826430
- Testing
- Inaticabtagene autoleucel Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Juventas Cell Therapy Ltd.
Hemophilia B
Safety of a New Type of Treatment Called Gene Transfer for the Treatment of Severe Hemophilia B
In this study a modified virus called adeno-associated virus (AAV) will be used to transfer a normal gene for human clotting factor IX into patients with severe hemophilia B (AAV human Factor IX vector).
- Trial name
- NCT00076557
- Testing
- Adeno-Associated Viral with Human Factor IX
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Avigen
Hemophilia A
Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens
The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging session. No study medication is given.
- Trial name
- NCT00927667
- Testing
- No Drug
- Where
- 15 sites in Germany, Greece and 4 more
- Volunteers
- 156 people
- Sponsor
- Bayer
Sepsis and Coagulopathy
The Safety And Efficacy of ART-123 in Subjects With Sepsis and Coagulopathy
The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.
- Trial name
- Scarlet2 (NCT03517501)
- Testing
- ART-123
- Sponsor
- Asahi Kasei Pharma America Corporation
Hemophilia A
Clinical Trial of NXT007 for the Prophylactic Treatment of Hemophilia A in Infants and Children
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis in pediatric patients aged 0 to 11 years with severe or moderate congenital hemophilia A without factor…
- Trial name
- ZEBRHA 3 (NCT07838194)
- Testing
- NXT007
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Congenital Bleeding Disorder, Haemophilia A
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy
- Trial name
- Explorer 1 (NCT01228669)
- Testing
- NNC 0172-0000-2021
- Where
- 16 sites in Austria, Denmark and 9 more
- Volunteers
- 52 people
- Sponsor
- Novo Nordisk A/S
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.
Stroke, Prevention and Control
An Observational Cross-sectional Study Evaluating the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism, Who Are on Treatment to Adequately Control Their Coagulation and Treated in Primary Care Centres
describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism on anticoagulant therapy who have changed their therapeutic…
- Conditions
- Stroke, Prevention and Control, Atrial Fibrillation
- Trial name
- SILVER-AP (NCT02470767)
- Testing
- Direct Oral Anticoagulant (DOAC)
- Where
- Spain
- Volunteers
- 792 people
- Sponsor
- Bayer
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
Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)
To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To…
- Trial name
- NCT01736475
- Testing
- Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, PEGylated Recombinant Factor VIII
- Where
- 72 sites in United States, Australia and 18 more
- Volunteers
- 159 people
- Sponsor
- Baxalta now part of Shire
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