Clinical trials: Coagulation Defect; Acquired
Acquired Bleeding Disorder, Trauma
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and…
- Trial name
- CONTROL (NCT00184548)
- Testing
- eptacog alfa (activated)
- Where
- 14 sites in United States, Brazil and 12 more
- Volunteers
- 554 people
- Sponsor
- Novo Nordisk A/S
Acquired Hemophilia A
Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A
This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with acquired hemophilia A.
- Trial name
- NCT01178294
- Testing
- OBI-1
- Where
- 12 sites in United States, Canada and 2 more
- Volunteers
- 29 people
- Sponsor
- Baxalta now part of Shire
Acquired Bleeding Disorder, Dengue Haemorrhagic Fever
Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever
This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with Dengue haemorrhagic fever (DHF).
- Trial name
- NCT01601613
- Testing
- activated recombinant human factor VII
- Where
- 9 sites in Malaysia, Philippines and 1 more
- Volunteers
- 28 people
- Sponsor
- Novo Nordisk A/S
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary…
- Trial name
- NCT01562574
- Testing
- activated recombinant human factor VII
- Where
- Australia
- Volunteers
- 82 people
- Sponsor
- Novo Nordisk A/S
Coagulopathy
Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Phase 2a study to assess the safety and efficacy of IV infused spray-dried solvent/detergent -treated plasma (Resusix) when compared with an equal volume of plasma frozen within 24 hours after phlebotomy (FP24) in patients with…
- Trial name
- NCT03700723
- Testing
- Resusix, FP24 (Frozen Plasma)
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Entegrion, Inc.
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.
- Trial name
- NCT00914589
- Testing
- catridecacog
- Where
- 32 sites in United States, Canada and 8 more
- Volunteers
- 479 people
- Sponsor
- Novo Nordisk A/S
Bleeding Disorder, Hypofibrinogenemia; Acquired
Adjusted Fibrinogen Replacement Strategy
The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired…
- Trial name
- AdFIrst (NCT03444324)
- Testing
- BT524, FFP/Cryo
- Where
- 19 sites in Belgium, Czechia and 5 more
- Volunteers
- 222 people
- Sponsor
- Biotest
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in…
- Trial name
- NCT00154427
- Testing
- activated recombinant human factor VII
- Where
- 63 sites in United States, Argentina and 12 more
- Volunteers
- 172 people
- Sponsor
- Novo Nordisk A/S
Acquired Bleeding Disorder, Bleeding During/Following Surgery
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in patients having undergone a hematopoietic stem…
- Trial name
- NCT01564563
- Testing
- standard therapy, activated recombinant human factor VII
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Novo Nordisk A/S
Acquired Bleeding Disorder, Trauma
Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients
This trial is conducted in Africa, Asia, Europe, Oceania and North America. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII given in conjunction with standard therapy in the treatment…
- Trial name
- NCT01563523
- Testing
- activated recombinant human factor VII
- Where
- 9 sites in Australia, Austria and 7 more
- Volunteers
- 283 people
- Sponsor
- Novo Nordisk A/S
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Factor VIIa in Acute Intracerebral Haemorrhage
This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracerebral haemorrhage.
- Trial name
- NCT00266006
- Testing
- eptacog alfa (activated)
- Where
- Japan
- Volunteers
- 90 people
- Sponsor
- Novo Nordisk A/S
Acquired Bleeding Disorder, Acquired Haemophilia
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).
- Conditions
- Acquired Bleeding Disorder, Acquired Haemophilia, Congenital Bleeding Disorder, Congenital FVII Deficiency
- Trial name
- NCT01561417
- Testing
- activated recombinant human factor VII
- Where
- France
- Volunteers
- 28 people
- Sponsor
- Novo Nordisk A/S
Acquired Thrombotic Thrombocytopenic Purpura
Study to Assess Efficacy and Safety of Anti-von Willebrand Factor (vWF) Nanobody in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
This study was a Phase II, single-blind, randomized, placebo-controlled trial to determine whether anti-vWF Nanobody is safe and effective as adjunctive treatment in patients with aTTP.
- Trial name
- TITAN (NCT01151423)
- Testing
- Caplacizumab
- Where
- 51 sites in United States, Australia and 11 more
- Volunteers
- 75 people
- Sponsor
- Ablynx, a Sanofi company
Acquired Bleeding Disorder, Spinal Fusion
Use of Activated Recombinant FVII in Spinal Surgery
This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in…
- Trial name
- NCT00102037
- Testing
- eptacog alfa (activated)
- Where
- 14 sites in United States
- Volunteers
- 50 people
- Sponsor
- Novo Nordisk A/S
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.
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage
This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in preventing early haematoma growth in acute…
- Trial name
- NCT01566786
- Testing
- activated recombinant human factor VII
- Where
- 9 sites in Australia, Denmark and 7 more
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S
Acquired Bleeding Disorder, Trauma
Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following…
- Trial name
- NCT01601457
- Testing
- activated recombinant human factor VII
- Where
- United Kingdom
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S
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
Congenital Bleeding Disorder, Congenital FVII Deficiency
Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics.
- Conditions
- Congenital Bleeding Disorder, Congenital FVII Deficiency, Glanzmann's Disease, Acquired Bleeding Disorder
- Trial name
- WIRK (NCT00697320)
- Testing
- eptacog alfa (activated)
- Where
- Germany
- Volunteers
- 64 people
- Sponsor
- Novo Nordisk A/S
Thrombotic Thrombocytopenic Purpura
A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Primary Objective: To evaluate the effect of caplacizumab on prevention of recurrence of aTTP (proportion of participants with a recurrence of aTTP) during the overall study period.
- Trial name
- NCT04074187
- Testing
- Caplacizumab (ALX-0081), Plasma exchange (PE), Corticosteroid treatment (Methylprednisolone or prednisolone)
- Where
- 12 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Sanofi