rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors

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


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.


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


Hemophilia A With Inhibitors


recombinant activated factor VII, recombinant activated factor VII


Vivantes Klinikum im Friedrichshain Haemophilia Care Center, Medical Center


Not yet recruiting


Fondazione Ospedale Maggiore Policlinico Milano

Results (where available)

View Results


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

Clinical Trials [3050 Associated Clinical Trials listed on BioPortfolio]

Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII is safe and effective in severely injured trauma patients by assessing...

Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B

Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD, efficacy and safety of a daily subcutaneous [SC] treatment regimen with MarzAA for bleeding prophy...

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

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 ...

Factor VIIa in Acute Intracerebral Haemorrhage

This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracere...

Use of Activated Recombinant Human Factor VII in Cardiac Surgery

This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the ma...

PubMed Articles [14212 Associated PubMed Articles listed on BioPortfolio]

A multicenter, open-label, phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors.

Emicizumab, a bispecific humanized monoclonal antibody, bridges activated factor (F) IX and FX to restore the function of missing activated FVIII in hemophilia A. Emicizumab prophylaxis in children wi...

What does the 'Cochrane database of systematic reviews' tell us about hemophilia?

: The purpose of this article is to review which data about hemophilia are currently provided by the Cochrane database of systematic reviews (CDBSR). Methodological consideration: All statements about...

The first reported case of acquired haemophilia A in which bleeding episodes were successfully treated via administration of a single-dose mixture of activated factor VIIa/X.

Adequate diagnosis of acquired hemophilia A.

Acquired hemophilia A (AHA) is a rare and life-threatening autoimmune hemorrhagic disorder where autoantibodies are developed against factor VIII. An early diagnosis is challenging and mandatory: an i...

Concurrent lymphoma and hemophilia B in a pediatric patient: A case report.

Lymphoma is the third most common cancer among children in the United States and Europe. Hemophilia is a congenital bleeding disorder characterized by deficiency of coagulation factor VIII or IX. Hemo...

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.

More From BioPortfolio on "rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors"

Quick Search

Relevant Topics

Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Searches Linking to this Trial