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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 [14322 Associated PubMed Articles listed on BioPortfolio]

Recombinant activated factor VII in approved indications: Update on safety.

A First-in-Human Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06741086, an anti-TFPI Monoclonal Antibody, in Healthy Volunteers.

Tissue factor pathway inhibitor (TFPI) is a protease inhibitor of tissue factor-activated coagulation factor VII (TF-FVIIa) complex and activated factor X (FXa). PF-06741086 is a monoclonal antibody t...

Treatment Regimens with Bypassing Agents in Patients with Hemophilia A and Inhibitors: A Survey from the Italian Association of Hemophilia Centers (AICE).

The development of neutralizing antibodies (inhibitors) against infused factor VIII currently represents the main complication of replacement therapy in patients with severe hemophilia A. Inhibitors, ...

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

Factor V Has Anticoagulant Activity in Plasma in the Presence of TFPIα: Difference between FV1 and FV2.

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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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