Clinical trials: Haemophilia
Congenital Bleeding Disorder, Haemophilia A
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State
This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT01562587
- Testing
- activated recombinant human factor VII
- Where
- 8 sites in Germany, Greece and 3 more
- Volunteers
- 18 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
This study was conducted in Africa, Europe, the Middle-East and South America. The primary objective of this registry was to observe the use of single dose and multi-dose use of activated recombinant human factor VII and to…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- ONE (NCT00703911)
- Testing
- eptacog alfa (activated)
- Where
- 16 sites in Algeria, Austria and 14 more
- Volunteers
- 102 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
PROPACT: Retrospective Prophylaxis Patient Case Collection
This study is conducted in Europe and North and South America. The primary aim of this observational study is to evaluate the frequency and pattern of bleeding episodes in haemophilia patients receiving preventative treatment…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- PROPACT (NCT00882778)
- Testing
- eptacog alfa (activated)
- Where
- 14 sites in United States, Argentina and 12 more
- Volunteers
- 86 people
- Sponsor
- Novo Nordisk A/S
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
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM® (Thromboelastometry) profiles of frequently bleeding…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01561924
- Testing
- eptacog alfa (activated)
- Where
- 7 sites in United States, Denmark and 2 more
- Volunteers
- 17 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX
This study is conducted in the United States of America (USA). The aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in patients with congenital haemophilia with…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- DOSE (NCT00710619)
- Testing
- activated recombinant human factor VII, Feiba VH
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database
This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT00853086
- Testing
- activated recombinant human factor VII
- Where
- United Kingdom
- Volunteers
- 139 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT00922792
- Testing
- activated recombinant human factor VII, long acting
- Where
- Spain
- Volunteers
- 8 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy
- Trial name
- NCT00951873
- Testing
- activated recombinant human factor VII, long acting
- Where
- United Kingdom
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B Patients
This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of NNC128-0000-2011, when administered i.v.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT01288391
- Testing
- NNC 0128-0000-2011
- Where
- 3 sites in Germany, Japan and 1 more
- Volunteers
- 15 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State
This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT01562457
- Testing
- activated recombinant human factor VII
- Where
- 3 sites in France, Germany and 1 more
- Volunteers
- 30 people
- Sponsor
- Novo Nordisk A/S
Haemophilia A, Haemophilia B
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.
- Trial name
- NCT02049099
- Where
- 12 sites in Belgium, France and 5 more
- Volunteers
- 1,658 people
- Sponsor
- Swedish Orphan Biovitrum
Haemostasis, Congenital Bleeding Disorder
Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
This study is conducted in the United States of America (USA). Tha aim of this study is bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).
- Conditions
- Haemostasis, Congenital Bleeding Disorder, Haemophilia B
- Trial name
- NCT02568202
- Testing
- No treatment given
- Where
- United States
- Volunteers
- 449 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Project to Update the Study of Congenital Haemophilia in Spain
This study is conducted in Europe. The aim of the study is to update the knowledge about the prevalence and severity of congenital haemophilia (A and B) in Spain.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- PUCHS (NCT01959555)
- Testing
- No treatment given
- Where
- Spain
- Volunteers
- 1,157 people
- Sponsor
- Novo Nordisk A/S
Haemophilia A
Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients
OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical…
- Trial name
- OPTIMS (NCT01436825)
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 2 sites in France, Italy
- Volunteers
- 69 people
- Sponsor
- Bayer
Congenital Bleeding Disorder, Haemophilia A
To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives
This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Haemophilia A With Inhibitors
- Trial name
- HERO (NCT02241694)
- Testing
- No treatment given
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B
This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT01220141
- Testing
- activated recombinant human factor VII
- Where
- 14 sites in Argentina, Austria and 12 more
- Volunteers
- 51 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors
This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT01234545
- Testing
- activated recombinant human factor VII
- Where
- 5 sites in Algeria, Morocco and 3 more
- Volunteers
- 35 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B
- Trial name
- NCT01949792
- Testing
- eptacog alfa (activated)
- Where
- Spain
- Volunteers
- 6 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects
This trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- Trial name
- NCT01272206
- Testing
- NNC 0128-0000-2011, NNC 0128-0000-2021
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- Novo Nordisk A/S