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rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors

2014-08-27 03:14:32 | BioPortfolio

Summary

The study evaluates the efficacy and safety of a prophylactic treatment with recombinant activated FVII in reducing the frequency of joint bleeds and the development of joint damage in children with hemophilia A who develop high-titer inhibitors.

Description

This is a multicentre, randomised, controlled study designed to gain evidence of the advantage of the prophylactic, daily treatment with recombinant activated FVII as compared to the conventional on demand therapy in reducing the bleeding frequency and preserving the orthopaedic status in hemophilic children with inhibitors.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hemophilia A With Inhibitors

Intervention

recombinant activated factor VII, recombinant activated factor VII

Location

Vivantes Klinikum im Friedrichshain Haemophilia Care Center, Medical Center
Berlin
Germany
10249

Status

Not yet recruiting

Source

Fondazione Ospedale Maggiore Policlinico Milano

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:32-0400

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PubMed Articles [13932 Associated PubMed Articles listed on BioPortfolio]

Factor XIII Co-Treatment with Hemostatic Agents in Hemophilia A Increases Fibrin α-Chain Crosslinking.

Hemophilia A results from the absence, deficiency, or inhibition of factor VIII (FVIII). Bleeding is treated with hemostatic agents (FVIII, recombinant activated factor VIIa [rFVIIa], anti-inhibitor c...

The pharmacokinetics and pharmacodynamics of single-dose and multiple-dose recombinant activated factor VII in patients with haemophilia A or B.

Monitoring recombinant activated factor VII (rFVIIa) treatment outcomes remains challenging. Thromboelastography (TEG) and the thrombin generation assay (TGA), measure coagulation dynamics over time a...

The interaction of factor V and tissue factor pathway inhibitor in a myeloma patient with acquired factor V deficiency.

Non-factor replacement therapy for haemophilia: a current update.

One of the most challenging issues facing us in the treatment of haemophilia is the development of alloantibodies against infused factor VIII (FVIII) or factor IX (FIX). Inhibitors render factor repla...

Hemophilia B Gene Therapy with a High-Specific-Activity Factor IX Variant.

The prevention of bleeding with adequately sustained levels of clotting factor, after a single therapeutic intervention and without the need for further medical intervention, represents an important g...

Medical and Biotech [MESH] Definitions

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).

Stable blood coagulation factor involved in the intrinsic pathway. The activated form XIa activates factor IX to IXa. Deficiency of factor XI is often called hemophilia C.

Activated form of factor XI. In the intrinsic pathway, Factor XI is activated to XIa by factor XIIa in the presence of cofactor HMWK; (HIGH MOLECULAR WEIGHT KININOGEN). Factor XIa then activates factor IX to factor IXa in the presence of calcium.

A hemostatic disorder characterized by a poor anticoagulant response to activated protein C (APC). The activated form of Factor V (Factor Va) is more slowly degraded by activated protein C. Factor V Leiden mutation (R506Q) is the most common cause of APC resistance.

Heat- and storage-stable plasma protein that is activated by tissue thromboplastin to form factor VIIa in the extrinsic pathway of blood coagulation. The activated form then catalyzes the activation of factor X to factor Xa.

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