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Hemophilia B clinical trials

View clinical trials related to Hemophilia B.

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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: NCT01555749 Completed - Healthy Clinical Trials

Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects

Start date: March 12, 2012
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered subcutaneously, at two different dose levels, in healthy Japanese subjects.

NCT ID: NCT01510418 Completed - Hemophilia A Clinical Trials

Socialization of Adult Men With Congenital Hemophilia A or B

PWBCD
Start date: May 2011
Phase: N/A
Study type: Observational

The goal of this pilot study is to understand the socialization of adult men with hemophilia living in the United States and their quality of life in order to improve comprehensive care for persons with congenital bleeding disorders. Studies in Europe suggest that despite medical, surgical, and biotechnology advances in care for persons with the congenital bleeding disorders hemophilia A and B, men with hemophilia have earlier work disability and health-related lower quality of life than men of the same age who do not have hemophilia in the general population. Congenital bleeding disorders are known to have medical and psychosocial impact not only in school but also in other activities, e.g. participation in sports beginning at a young age. The psychosocial impact of living with a congenital bleeding disorder has been studied and described in childhood. The support relationships in childhood include parents and primary family of origin and these supports are generally considered in pediatric comprehensive care models. Support relationships in adulthood have not been well described or studied. The role of spouse and significant others (SSO) of PWCBD in health care is of interest for the delivery of adult comprehensive care as well as to understand their contribution to the health-related quality of life of PWCBD. Additionally, this study seeks to learn of the impact of congenital bleeding disorders for the SSO. The study uses self-reported medical and social information questionnaires, health-related quality of life surveys, and confidential interview. Results of this study may guide how comprehensive care and support are provided to adult persons with congenital bleeding disorders by hemophilia treatment programs. This study focuses on PWCBD with hemophilia A or B as a model for the experience of persons with other congenital bleeding disorders.

NCT ID: NCT01507896 Completed - Hemophilia B Clinical Trials

BAX 326 Surgery Study in Hemophilia B Patients

Start date: December 19, 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in subjects with severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B undergoing major or minor elective or emergency surgical, dental or other invasive 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: NCT01496274 Completed - Hemophilia B Clinical Trials

A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B

Start date: February 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.

NCT ID: NCT01488994 Completed - Hemophilia B Clinical Trials

BAX 326 Pediatric Study

Start date: December 20, 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess BAX 326 pharmacokinetic parameters, to evaluate its hemostatic efficacy, safety, immunogenicity, and changes in health-related quality of life in pediatric patients.

NCT ID: NCT01467427 Completed - Clinical trials for Congenital Bleeding Disorder

Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.

paradigmâ„¢5
Start date: May 16, 2012
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.