Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor
Summary
The purpose of the study is to determine the efficacy, safety, and health-related quality of life benefits with FEIBA NF prophylactic treatment as compared with on-demand treatment. The study will be conducted globally and will consist of two arms. Eligible subjects will be randomized to undergo a 12-month period of either prophylactic or on-demand therapy.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Hemophilia A
Intervention
Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated), Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)
Location
RUSH University Medical Center
Chicago
Illinois
United States
60611
Status
Recruiting
Source
Baxter Healthcare Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00851721
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Factor Viii
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.
Factor Viiia
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.
Von Willebrand Factor
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.
Factor Ix
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).
Deamino Arginine Vasopressin
A synthetic analog of the pituitary hormone, ARGININE VASOPRESSIN. Its action is mediated by the VASOPRESSIN receptor V2. It has prolonged antidiuretic activity, but little pressor effects. It also modulates levels of circulating FACTOR VIII and VON WILLEBRAND FACTOR.
Clinical Trials
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This study is conducted in the United States of America (USA). The aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in...
Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity
Congenital and acquired thrombophilia were identified as risk factors for thrombosis in systemic vessels.Thrombophilias have also been recently found to be associated with preeclampsia, in...
Genetic Susceptibility to Factor VIII Inhibitors
This international study will identify genetic factors that may influence the development of inhibitory antibodies in patients with hemophilia A after treatment with factor VIII. Bleeding...
Trial to Evaluate the Efficacy and Safety of a New Formulation of Kogenate for Hemophilia A
Part A of the study will compare the pharmacokinetics (bioequivalence) of a new formulation of Kogenate (recombinant Factor VIII) with the current formulation. Part B will evaluate the sa...
PubMed Articles
Case of acquired hemophilia with factor VIII inhibitor in a mother and newborn.
We report a mother and newborn in the puerperium with hemorrhage secondary to factor VIII inhibitor. A 31-year-old gravida 1 para 1 delivered at a local clinic with a massive postpartum hemorrhage. Th...
Factor-Eight-Inhibitor-Bypassing-Activity (FEIBA) is a bypassing-agent used to control spontaneous bleeding or cover surgical interventions in Haemophiliacs who develop neutralizing antibodies against...
Membrane binding properties of the factor VIII C2 domain.
Factor VIII functions as a cofactor for factor IXa in a membrane-bound enzyme complex. Membrane binding accelerates activity of the factor VIIIa-factor IXa complex approximately 100,000-fold and the m...
Acquired factor VIII inhibitor (AFI) is a rare disorder and is even more uncommon in multiple myeloma patients, with only five cases reported in literature. Solid and hematologic malignancies, autoimm...
Pharmacotherapy of haemophilia A.
Introduction: Haemophilia A is due to factor VIII (FVIII) deficiency. The main treatment is replacement therapy with FVIII concentrates. However, these concentrates carried a high risk of blood-borne...
