Clinical trials: Coagulation Defect; Acquired
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
Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)
The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic…
- Trial name
- NCT02878603
- Testing
- Caplacizumab, Standard of Care
- Where
- 45 sites in United States, Austria and 11 more
- Volunteers
- 104 people
- Sponsor
- Sanofi
Acquired Bleeding Disorder, Trauma
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma
This trial is conducted in the United States of America (USA). The purpose of this study is to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to Trauma Please note that this trial and…
- Trial name
- NCT00323570
- Testing
- activated recombinant human factor VII
- Where
- 42 sites in United States
- Sponsor
- Novo Nordisk A/S
Liver Disease
Clinical Study of Lyophilized Plasma in Patients With Liver Disease
A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in patients with liver disease.
- Trial name
- NCT01547078
- Testing
- Lyophilized Plasma, Licensed Plasma
- Sponsor
- HemCon Medical Technologies, Inc
Liver Decompensation, Hepatocellular Carcinoma
The Second Multicenter Hemophilia Cohort Study
The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV).
- Conditions
- Liver Decompensation, Hepatocellular Carcinoma, Non-Hodgkin Lymphoma
- Trial name
- NCT00341705
- Where
- 48 sites in United States, Brazil and 6 more
- Volunteers
- 2,565 people
- Sponsor
- National Cancer Institute (NCI)
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
Thrombotic Thrombocytopenic Purpura
.German TTP-Registry (Thrombotic Thrombocytopenic Purpura)
Open, multi-center, observational, prospective cohort study, only disease-indicated treatment, in patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of…
- Trial name
- RGTTP (NCT05389007)
- Where
- Germany
- Volunteers
- 156 people
- Sponsor
- Johannes Gutenberg University Mainz
Acquired Bleeding Disorder, Trauma
Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury
This study is conducted in North America. The purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.
- Trial name
- NCT00124293
- Testing
- activated recombinant human factor VII
- Where
- 2 sites in United States, Canada
- Volunteers
- 63 people
- Sponsor
- Novo Nordisk A/S
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
Post Partum Hemorrhage, Fibrinogenolysis; Hemorrhage
Patient Blood Management for Massive Obstetric Hemorrhage
Obstetric Hemorrhage continues to be the first cause of maternal morbidity and mortality around the world especially in middle to low income countriesThe blood components are high value resources; however, its use has been shown…
- Conditions
- Post Partum Hemorrhage, Fibrinogenolysis; Hemorrhage, Fibrinogen; Deficiency, Acquired, Massive Hemorrhage
- Trial name
- NCT03784794
- Testing
- Thromboelastometry, Standard Coagulation Test, Fibrinogen Concentrate Human
- Where
- Mexico
- Volunteers
- 100 people
- Sponsor
- Angel Augusto Perez Calatayud
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
Hepatic Vein Thromboses, Hepatic Venous Outflow Obstruction
Global Coagulation Assessment in Portal Vein Thrombosis and Budd-Chiari Syndrome
Portal vein thrombosis is defined as partial or complete occlusion of the portal vein lumen by the blood clot or its replacement by multiple collateral vessels with the hepato-petal flow, known as 'portal cavernoma'.
- Conditions
- Hepatic Vein Thromboses, Hepatic Venous Outflow Obstruction, Portal Vein Thrombosis, Portal Hypertension, Noncirrhotic
- Trial name
- Liv-Thrombus (NCT05123326)
- Testing
- Rotational thromboelastometry, Genetic tests for Thrombophilia, ELISA tests/ Functional assays
- Where
- India
- Volunteers
- 300 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth…
- Trial name
- NCT01563445
- Testing
- activated recombinant human factor VII
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Novo Nordisk A/S
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 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
Blood Loss, Surgical, Blood Loss Requiring Transfusion
ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery
Need for perioperative blood transfusion is still high in certain types of oncological abdominal surgery. Allogeneic blood transfusion may be detrimental in cancer patients undergoing a potentially curative resection of malignant…
- Conditions
- Blood Loss, Surgical, Blood Loss Requiring Transfusion, Coagulation Defect; Acquired
- Trial name
- ROTEM-SUR (NCT03993977)
- Testing
- Rotational thromboelastometry, Conventional treatment
- Where
- Finland
- Sponsor
- Tampere University Hospital
Von Willebrand Diseases
Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients
ECMO has improved the outcome of heart or respiratory failure and carcinogenic shock and are increasingly used. However bleeding complications occurring in up to 50% of patients are poorly understood and worsen the overall…
- Trial name
- WITECMO-H (NCT03070912)
- Where
- 7 sites in France
- Volunteers
- 257 people
- Sponsor
- University Hospital, Lille
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
Hemophilia A
Acquired Hemophilia A and Autoimmunity. Study of Lymphocyte Populations and Myeloid-Derived Suppressor Cells
Acquired hemophilia A is a rare condition of hemostasis secondary to the development of antibodies against factor VIII. This is a potentially serious pathology that can be life-threatening due to the major risk of bleeding caused…
- Trial name
- IMMUNHEMAC (NCT04805021)
- Testing
- no intervention
- Where
- 2 sites in France
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Nantes University Hospital
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