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Safety and Efficacy of Recombinant Factor VIII (N8) in Male Children Previously Treated With Haemophilia A

2014-08-27 03:13:08 | BioPortfolio

Summary

This trial is conducted in Asia, Europe, Japan and the United States of America (USA).

The aim of this clinical trial is to investigate the safety and efficacy of N8 in male previously treated paediatric subjects with haemophilia A.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Haemophilia A

Intervention

recombinant factor VIII (N8), recombinant factor VIII (N8)

Location

Novo Nordisk Clinical Trial Call Center
Phoenix
Arizona
United States
85016-7710

Status

Recruiting

Source

Novo Nordisk

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:08-0400

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Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

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BAX 855 PK-Guided Dosing

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PubMed Articles [10921 Associated PubMed Articles listed on BioPortfolio]

Break-through bleeding in relation to pharmacokinetics of Factor VIII in paediatric patients with severe haemophilia A.

As the pharmacokinetics (PK) of factor VIII (FVIII) is individualized in children with haemophilia A (HA), PK parameters may be indicators of patients' bleeding phenotype and instruction for their per...

Recombinant factor VIII Fc fusion protein for immune tolerance induction in patients with severe haemophilia A with inhibitors-A retrospective analysis.

Immune tolerance induction (ITI) is the gold standard for eradication of factor VIII inhibitors in severe haemophilia A; however, it usually requires treatment for extended periods with associated hig...

Cross-evaluation of Pharmacokinetic-Guided Dosing Tools for Factor VIII.

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Factor VIII products and inhibitor development in previously treated patients with severe or moderately severe haemophilia A: a systematic review.

Patients with severe haemophilia A who have been treated extensively with factor VIII (FVIII) products face a low but potentially serious risk of inhibitor development. It is unknown why these patient...

Frequencies of intron 1 and 22 inversions of factor VIII gene: A first report in Afghan patients with severe haemophilia A.

Medical and Biotech [MESH] Definitions

Blood-coagulation factor VIII. Antihemophilic factor that is part of the factor VIII/von Willebrand factor complex. Factor VIII is produced in the liver and acts in the intrinsic pathway of blood coagulation. It serves as a cofactor in factor X activation and this action is markedly enhanced by small amounts of thrombin.

Activated form of factor VIII. The B-domain of factor VIII is proteolytically cleaved by thrombin to form factor VIIIa. Factor VIIIa exists as a non-covalent dimer in a metal-linked (probably calcium) complex and functions as a cofactor in the enzymatic activation of factor X by factor IXa. Factor VIIIa is similar in structure and generation to factor Va.

Storage-stable blood coagulation factor acting in the intrinsic pathway. Its activated form, IXa, forms a complex with factor VIII and calcium on platelet factor 3 to activate factor X to Xa. Deficiency of factor IX results in HEMOPHILIA B (Christmas Disease).

A non-fibrillar collagen originally found in DESCEMET MEMBRANE. It is expressed in endothelial cell layers and in tissues undergoing active remodeling. It is heterotrimer comprised of alpha1(VIII) and alpha2(VIII) chains.

A high-molecular-weight plasma protein, produced by endothelial cells and megakaryocytes, that is part of the factor VIII/von Willebrand factor complex. The von Willebrand factor has receptors for collagen, platelets, and ristocetin activity as well as the immunologically distinct antigenic determinants. It functions in adhesion of platelets to collagen and hemostatic plug formation. The prolonged bleeding time in VON WILLEBRAND DISEASES is due to the deficiency of this factor.

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