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Haemophilia B With Inhibitors clinical trials

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NCT ID: NCT01563471 Completed - Healthy Clinical Trials

Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers

Start date: October 2001
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT01561924 Completed - Clinical trials for Congenital Bleeding Disorder

Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography

Start date: November 2005
Phase: Phase 1
Study type: Interventional

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 haemophilia subjects with inhibitors in a non-bleeding state.

NCT ID: NCT01561417 Completed - Healthy Clinical Trials

Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects

Start date: April 2006
Phase: Phase 1
Study type: Interventional

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).

NCT ID: NCT01561391 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery

Start date: April 1998
Phase: Phase 4
Study type: Interventional

This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.

NCT ID: NCT01503567 Completed - Clinical trials for Congenital Bleeding Disorder

Epidemiological Study on Haemophilia Care and Orthopaedic Status in Developing Countries

HAEMOcare
Start date: January 2012
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01392547 Completed - Clinical trials for Congenital Bleeding Disorder

Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

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Start date: July 2011
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

NCT ID: NCT01322620 Completed - Clinical trials for Congenital Bleeding Disorder

Survey Evaluating the Psychosocial Effects of Living With Haemophilia

HERO
Start date: June 3, 2011
Phase: N/A
Study type: Observational

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.

NCT ID: NCT00951405 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors

Start date: September 1, 2009
Phase: Phase 2
Study type: Interventional

This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical trial is to investigate the safety and the efficacy of a prophylactic treatment option with long acting coagulation factor VII (LA-rFVIIa) for haemophilia patients with inhibitors.

NCT ID: NCT00882778 Completed - Clinical trials for Congenital Bleeding Disorder

PROPACT: Retrospective Prophylaxis Patient Case Collection

PROPACT
Start date: April 2009
Phase: N/A
Study type: Observational

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 with activated recombinant human factor VII. The secondary aim is to evaluate which patients are selected for this treatment, the dose and dose intervals used, and the safety of activated recombinant human factor VII when used as prevention. The study also aims to increase understanding of the unmet medical need and clinical relevance of preventative treatment in haemophilia patients.

NCT ID: NCT00710619 Completed - Clinical trials for Congenital Bleeding Disorder

Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX

DOSE
Start date: June 2008
Phase: N/A
Study type: Observational

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 inhibitors to factors VIII and IX. We are further investigating how bleeding episodes affect the quality of life of the patient and their family or caregivers.