Advertisement

Topics

Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

2014-08-27 03:19:38 | BioPortfolio

Summary

The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Blood Coagulation Disorders

Intervention

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Location

Many locations
Mexico

Status

Recruiting

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:38-0400

Clinical Trials [633 Associated Clinical Trials listed on BioPortfolio]

Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980

The primary objective of this study is to determine the pharmacokinetic profile after single administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22 mg...

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...

Extension at 10 Years of the: "Observational Study Evaluating Efficacy and Costs of Secondary Prophylaxis vs On-demand Therapy With Kogenate Bayer in Patients With Severe Haemophilia A."

Following the performance of the POTTER observational study, whose primary objective was to collect data on the benefits of secondary prophylaxis versus on demand treatment in terms of pre...

Kogenate Liplong Study - BAY 79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent ...

Trial to Evaluate the Pharmacokinetics and Safety Profile of BAY94-9027 Following Single and Multiple Dose Administration

The purpose of this study is to describe the pharmacokinetics (PK) of BAY94-9027(the test drug). Pharmacokinetics means that we will measure how well the study drug corrects the factor VI...

PubMed Articles [12689 Associated PubMed Articles listed on BioPortfolio]

The effects of transport temperature and time on routine and specialized coagulation assays.

: Coagulation laboratories have largely stopped transporting whole blood specimens on ice, due to adverse effects on factor VIII, von Willebrand factor, and the prothrombin time. However, it is unknow...

An update on factor XI structure and function.

Factor XI (FXI) is the zymogen of a plasma protease, factor XIa (FXIa), that contributes to thrombin generation during blood coagulation by proteolytic activation of several coagulation factors, most ...

Purification and characterization of a new highly pure, double virus inactivated von Willebrand factor concentrate.

: Desmopressin-unresponsive von Willebrand disease patients are treated with substitutive therapy, with both pure von Willebrand factor (vWF) and factor VIII/vWF concentrates. We developed a new purif...

Within-subject biological variation of activated partial thromboplastin time, prothrombin time, fibrinogen, factor VIII and von Willebrand factor in pregnant women.

During pregnancy, interpretation of results from coagulation parameters can be difficult as the physiological changes that occur may affect the biochemical parameters. The aim of this study was to des...

Can the plasmaderived factor VIII still play a role in the treatment of acquired hemophilia A at the time of new drugs?

: Bypassing agents are the first-line therapy in the treatment of acquired hemophilia A (AHA), but not the only one. Other options as recombinant porcine factor VIII or plasmaderived concentrates (pdF...

Medical and Biotech [MESH] Definitions

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.

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 activated by contact with the subendothelial surface of an injured vessel. Along with prekallikrein, it serves as the contact factor that initiates the intrinsic pathway of blood coagulation. Kallikrein activates factor XII to XIIa. Deficiency of factor XII, also called the Hageman trait, leads to increased incidence of thromboembolic disease. Mutations in the gene for factor XII that appear to increase factor XII amidolytic activity are associated with HEREDITARY ANGIOEDEMA TYPE III.

The classic hemophilia resulting from a deficiency of factor VIII. It is an inherited disorder of blood coagulation characterized by a permanent tendency to hemorrhage.

Storage-stable glycoprotein blood coagulation factor that can be activated to factor Xa by both the intrinsic and extrinsic pathways. A deficiency of factor X, sometimes called Stuart-Prower factor deficiency, may lead to a systemic coagulation disorder.

More From BioPortfolio on "Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...


Searches Linking to this Trial