Early Prophylaxis Immunologic Challenge (EPIC) Study
Summary
The purpose of the study is to assess if a once-weekly prophylactic regimen of 25 IU/kg ADVATE started at or before 1 year of age and before the onset of a severe bleeding phenotype (ie, joint bleeding), together with the minimization of immunological danger signals, can reduce the incidence rate of inhibitor formation in PUPs with severe and moderately severe hemophilia A.
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Hemophilia A
Intervention
Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM)
Location
Indianapolis
Indiana
United States
Status
Terminated
Source
Baxter Healthcare Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01376700
- Information obtained from ClinicalTrials.gov on April 30, 2013
Medical and Biotech [MESH] Definitions
Factor Xi Deficiency
A hereditary deficiency of blood coagulation factor XI (also known as plasma thromboplastin antecedent or PTA or antihemophilic factor C) resulting in a systemic blood-clotting defect called hemophilia C or Rosenthal's syndrome, that may resemble classical hemophilia.
Evans Blue
An azo dye used in blood volume and cardiac output measurement by the dye dilution method. It is very soluble, strongly bound to plasma albumin, and disappears very slowly.
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.
Hypoalbuminemia
A condition in which albumin level in blood (SERUM ALBUMIN) is below the normal range. Hypoalbuminemia may be due to decreased hepatic albumin synthesis, increased albumin catabolism, altered albumin distribution, or albumin loss through the urine (ALBUMINURIA).
Plasma Exchange
Removal of plasma and replacement with various fluids, e.g., fresh frozen plasma, plasma protein fractions (PPF), albumin preparations, dextran solutions, saline. Used in treatment of autoimmune diseases, immune complex diseases, diseases of excess plasma factors, and other conditions.
Clinical Trials
The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the treatment of hemophilia A patients who have not been treated with factor VIII before.
The purpose of this study is to compare the safety and efficacy of continuous infusion versus intermittent bolus infusion employing rAHF-PFM, a recombinant antihemophilic factor manufactur...
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A patients undergoing surgery.
Pharmacokinetic Study of Advate Reconstituted in 2 mL Sterile Water for Injection
The purpose of this study is to determine the pharmacokinetics and safety of rAHF-PFM reconstituted in 2 mL sterile water for injection (SWFI) and compare with those of rAHF-PFM reconstitu...
The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the treatment of children with hemophilia A. The study consists of 2 parts. Part 1 of the study is a phar...
PubMed Articles
Summary. Recombinant FVIII (rFVIII) has become the best choice for treating bleeding of haemophilia A patients. A plasma- and albumin-free recombinant FVIII (rAHF-PFM, ADVATE(®) ), as the third ge...
Mycophenolic acid (MPA) is 98-99% bound to albumin. Because MPA is restrictively cleared and has a low extraction coefficient, increase in its free fraction related to decreased albumin binding result...
The addition of proteins to in vitro systems influences the free concentration of the test compound in the medium. The objective of this study was to set up a negligible depletion-solid phase microext...
BACKGROUND: Parvovirus B19 (B19V) is a small, nonenveloped virus that typically causes a benign flu-like illness that occurs most frequently in childhood. The virus is resistant to current viral inact...
Objective-To compare the diagnostic performance of a point-of-care (POC) analyzer with that of established methods for the measurement of plasma IgG, total protein, and albumin concentrations in neona...
