Clinical trials: Haemophilia B With Inhibitors
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors Under Normal Clinical Practice
This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) under normal clinical practice conditions.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01579955
- Testing
- eptacog alfa (activated)
- Where
- Japan
- Volunteers
- 321 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery
This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing surgery under normal clinical practice…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01579968
- Testing
- eptacog alfa (activated)
- Where
- Japan
- Volunteers
- 86 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Survey Evaluating the Psychosocial Effects of Living With Haemophilia
This study is conducted in Africa, Asia, Europe, North America and South America. The purpose of the survey 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 (NCT01322620)
- Testing
- No treatment given
- Where
- 3 sites in Canada, Spain and 1 more
- Volunteers
- 1,236 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
Congenital Bleeding Disorder, Haemophilia A
Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries
This study is conducted in Africa and Asia. The aim of this study is to evaluate in the participating countries the orthopaedic status and the degree of arthropathy of severe haemophilia patients in general.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B
- Trial name
- HAEMOcare (NCT01503567)
- Testing
- No treatment given
- Where
- 4 sites in India, Morocco and 2 more
- Volunteers
- 282 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia
This study is conducted in the United States of America (USA). The aim of the study is to assess the impact of pain on functional impairment and quality of life in adult persons with hemophilia (PWH) with and without inhibitors…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B
- Trial name
- NCT01988532
- Testing
- No treatment given
- Where
- United States
- Volunteers
- 381 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors, Healthy
- Trial name
- NCT01563471
- Testing
- activated recombinant human factor VII
- Where
- France
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia
This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA). The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT00108758
- Testing
- activated recombinant human factor VII
- Where
- 37 sites in United States, Argentina and 10 more
- Volunteers
- 23 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Trial of NovoSeven® in Haemophilia - Joint Bleeds
This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT00108797
- Testing
- eptacog alfa (activated), Feiba VH
- Where
- 20 sites in United States
- Volunteers
- 42 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT00571584
- Testing
- activated recombinant human factor VII
- Where
- 18 sites in France, Hungary and 5 more
- Volunteers
- 24 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, 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
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
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 the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B
- Trial name
- NCT02084810
- Testing
- activated recombinant human factor VII, eptacog alfa (activated)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Severe Haemophilia A With Inhibitors
Case-control Pilot Study of the Immune Modulating Effect of FEIBA on Patients With Haemophilia A and Inhibitors
This study aims to evaluate the immunomodulatory effect of FEIBA® in patients with severe haemophilia A and inhibitors.
- Trial name
- NCT02018393
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Hospital Universitario La Paz