Document Detail

Human coagulation factor FVIIa (recombinant) in the management of limb-threatening bleeds unresponsive to alternative therapies: results from the NovoSeven emergency-use programme in patients with severe haemophilia or with acquired inhibitors.
MedLine Citation:
PMID:  10870806     Owner:  NLM     Status:  MEDLINE    
This open-label, emergency-use study evaluated the efficacy and safety of activated human coagulation factor VIIa (recombinant) (rFVIIa) (NovoSeven; Novo Nordisk Pharmaceuticals, Inc., New Jersey, USA) in treating limb-threatening joint or muscle bleeds in 17 patients with haemophilia A or B and six patients with acquired inhibitors to factor VIII or factor IX. All patients had previously failed on one or more alternative therapies. rFVIIa administration was effective or partially effective in controlling joint or muscle bleeds in 34 out of 35 (97%) bleeding episodes; in 23 patients, 14 of 17 (82%) muscle bleeds and 16 of 18 (89%) joint bleeds were effectively controlled. These findings suggest that rFVIIa is an effective and well-tolerated therapeutic option in the management of joint or muscle haemorrhage in patients with haemophilia and in patients with acquired inhibitors.
S Arkin; F Blei; J Fetten; R Foulke; G S Gilchrist; M A Heisel; N Key; C T Kisker; C Kitchen; F E Shafer; P C Shah; D Strickland
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Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis     Volume:  11     ISSN:  0957-5235     ISO Abbreviation:  Blood Coagul. Fibrinolysis     Publication Date:  2000 Apr 
Date Detail:
Created Date:  2000-10-30     Completed Date:  2000-10-30     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  9102551     Medline TA:  Blood Coagul Fibrinolysis     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  255-9     Citation Subset:  IM    
Division of Pediatrics, Haemotology/Oncology, Mount Sinai School of Medicine, New York, New York 10029, USA.
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MeSH Terms
Antibodies / blood
Child, Preschool
Extremities / physiopathology
Factor IX / immunology
Factor VII / administration & dosage*
Factor VIII / immunology
Factor VIIa
Hemophilia A / blood,  drug therapy*,  immunology,  physiopathology
Hemophilia B / blood,  drug therapy*,  immunology,  physiopathology
Hemorrhage / drug therapy
Injections, Intravenous
Middle Aged
Recombinant Proteins / administration & dosage
Salvage Therapy
Reg. No./Substance:
0/Antibodies; 0/Recombinant Proteins; 0/recombinant FVIIa; 9001-25-6/Factor VII; 9001-27-8/Factor VIII; 9001-28-9/Factor IX; EC VIIa

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

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