Document Detail

Purified factor IX using monoclonal immunoaffinity technique: clinical trials in hemophilia B and comparison to prothrombin complex concentrates.
MedLine Citation:
PMID:  1531035     Owner:  NLM     Status:  MEDLINE    
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 (II, VII, and X). Mononine was evaluated for in vivo recovery, half-life, and for its safety and efficacy in 10 patients with hemophilia B. The in vivo recovery of factor IX with Mononine was a 0.67 +/- 0.14 U/dL (mean +/- SD) increase per 1U/kg of infused factor IX, and the biologic half-life (t1/2), determined using the terminal phase of elimination, was 22.6 +/- 8.1 hours. Comparison of in vivo recovery of other vitamin K-dependent factors following a single infusion of either Mononine or PCC showed that, whereas Mononine infusion caused no changes in other vitamin K-dependent factors or in prothrombin activation fragment (F1+2), PCC infusion was associated with significant increases of factors II (2.7 U/dL per 1 U/dL of IX increase) and X (2.2 U/dL for 1 U/dL for 1 U/dL of IX). Patients who used Mononine as their sole therapeutic material during the 12-month period showed an excellent response in hemostasis for their bleeding episodes. Their experience with long-term use of Mononine was at least equivalent to their previous experience with PCC in the frequency and amount of factor usage. No patients developed antibody against mouse IgG or an increase in IX inhibitor during the 12-month period. These results indicate that monoclonal antibody-purified factor IX concentrate provides hemostatically effective factor IX replacement while avoiding extraneous thrombogenic substances.
H C Kim; C W McMillan; G C White; G E Bergman; M W Horton; P Saidi
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Publication Detail:
Type:  Clinical Trial; Controlled Clinical Trial; Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Blood     Volume:  79     ISSN:  0006-4971     ISO Abbreviation:  Blood     Publication Date:  1992 Feb 
Date Detail:
Created Date:  1992-02-27     Completed Date:  1992-02-27     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  7603509     Medline TA:  Blood     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  568-75     Citation Subset:  AIM; IM    
Division of Hematology-Oncology, UMDNJ-Robert Wood Johnson Medical School, New Brunswick.
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MeSH Terms
Antibodies, Monoclonal
Antithrombin III / metabolism
Chromatography, Affinity
Factor IX / isolation & purification,  pharmacokinetics,  therapeutic use*
Factor VII / metabolism
Factor X / metabolism
Glycoproteins / metabolism
Hemophilia B / drug therapy*
Protein C / metabolism
Protein S
Prothrombin / metabolism,  pharmacokinetics,  therapeutic use
Time Factors
Grant Support
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Glycoproteins; 0/Protein C; 0/Protein S; 9000-94-6/Antithrombin III; 9001-25-6/Factor VII; 9001-26-7/Prothrombin; 9001-28-9/Factor IX; 9001-29-0/Factor X

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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