Principles for clinical trials of coagulation factor IX products
نویسندگان
چکیده
منابع مشابه
Coagulation Factor IX for Hemophilia B Therapy
Factor IX is a zymogen enzyme of the blood coagulation cascade. Inherited absence or deficit of the IX functional factor causes bleeding disorder hemophilia B, which requires constant protein replacement therapy. Reviewed herein are the current state in the manufacturing of FIX, improved variants of the recombinant protein for therapy, transgenic organisms for obtaining FIX, and the advances in...
متن کاملPurified Factor IX Using Monoclonal Immunoaffinity Technique: Clinical Trials
Replacement therapy for hemophilia B (factor IX deficiency) using prothrombin complex concentrate (PCC) has been associated with serious complications of thromboembolic events and transmission of viral infections. Monoclonal antibody-purified factor IX (Mononine) provides a highly purified factor IX concentrate, while eliminating other vitamin K-dependent factors (11, VII, and X). Mononine was ...
متن کاملProteolytic processing of human coagulation factor IX by plasmin.
Previous studies have shown that thrombin generation in vivo caused a 92% decrease in factor IX (F.IX) activity and the appearance of a cleavage product after immunoblotting that comigrated with activated F.IX (F.IXa). Under these conditions, the fibrinolytic system was clearly activated, suggesting plasmin may have altered F.IX. Thus, the effect(s) of plasmin on human F.IX was determined in vi...
متن کاملChromogenic Factor IX Assay for Clinical Use
A chromogenic factor IX assay is developed which requires only two timedependent steps. Diluted plasma is mixed with a reagent containing factors VIII and X. The reaction is started by addition of a reagent containing factor XI", thrombin, CaCl2, and phospholipids. Then factor XIu activates factor IX if present, thrombin activates factor VIII, and subsequently the complete factor X activating c...
متن کاملProteolytic inactivation of blood coagulation factor IX by thrombin.
Coagulation factor IX is a vitamin K-dependent glycoprotein that circulates in blood as a precursor of a serine protease. Incubation of human factor IX with human alpha-thrombin resulted in a time and enzyme concentration-dependent cleavage of factor IX yielding a molecule composed of a heavy chain (mol wt 50,000) and a doublet light chain (mol wt 10,000). The proteolysis of factor IX by thromb...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Pacific Medical Journal
سال: 2020
ISSN: 1609-1175
DOI: 10.34215/1609-1175-2020-3-11-18