Document Detail


Recombinant factor VIIa for patients with inhibitors to factor VIII or IX or factor VII deficiency.
MedLine Citation:
PMID:  10469179     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Inhibitors to factor VIII (FVIII) or IX (FIX) in patients with haemophilia A or B create a challenging problem for the treatment of these patients. Recombinant FVIIa (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) is a realistic treatment option, owing to its specific mode of action and lack of immunogenicity. This was a multicentre, open-label, compassionate-use trial in patients with severe haemophilia A (FVIII:C < 1%) or B (FIX:C < 1%) with inhibitors, acquired antibodies to FVIII or FIX, or FVII deficiency (FVII:C < 5%), for whom alternative therapies had failed or were contraindicated. Patients received rFVIIa treatment for life- or limb-threatening bleeding episodes or for coverage during essential surgery. The mean rFVIIa dose was approximately 90 microg kg-1 for haemophilia A/B and acquired inhibitor patients, and 25 microg kg-1 for FVII-deficient patients. Efficacy data for 67 treatment episodes (45 bleeding episodes, 22 surgical procedures) are presented; seven patients were treated for a concurrent serious bleeding episode and surgical procedure. At the end of treatment, rFVIIa was effective or partially effective in 85% of serious bleeding episodes. During surgery, bleeding was assessed as none or less than or equivalent to normal in 91% of surgical procedures; postoperatively, 91% of procedures were associated with no or minimal oozing. During 60 separate treatment episodes, 26 adverse events (22 nonserious, four serious) were reported in 15 patients, during 17 bleeding episodes or surgical procedures. Only 10 were considered as having a possible, probable, or unknown relationship with rFVIIa; of these, fever (n=2) and thrombophlebitis (n=3) were the most common. There was no evidence of disseminated intravascular coagulation. In conclusion, rFVIIa is an effective, well-tolerated treatment for serious bleeding episodes and bleeding associated with surgical procedures in patients with severe haemophilia A/B with inhibitors, acquired inhibitors, or FVII deficiency.
Authors:
I Scharrer
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Publication Detail:
Type:  Clinical Trial; Controlled Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  Haemophilia : the official journal of the World Federation of Hemophilia     Volume:  5     ISSN:  1351-8216     ISO Abbreviation:  Haemophilia     Publication Date:  1999 Jul 
Date Detail:
Created Date:  2000-08-11     Completed Date:  2000-08-11     Revised Date:  2009-10-21    
Medline Journal Info:
Nlm Unique ID:  9442916     Medline TA:  Haemophilia     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  253-9     Citation Subset:  IM    
Affiliation:
Klinikum der Johann Wolfgang Goethe-Universität, Zentrum der Inneren Medizin, Frankfurt am Main, Germany.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Blood Loss, Surgical / prevention & control
Child
Child, Preschool
Factor IX / immunology,  therapeutic use
Factor VII Deficiency / drug therapy
Factor VIII / immunology,  therapeutic use
Factor VIIa / standards,  therapeutic use*,  toxicity
Female
Gastrointestinal Hemorrhage / drug therapy,  etiology
Germany
Hemarthrosis / drug therapy,  etiology
Hemophilia A / complications,  drug therapy,  immunology
Hemophilia B / complications,  drug therapy,  immunology
Hemorrhage / drug therapy
Humans
Infant
Intracranial Hemorrhages / drug therapy,  etiology
Intracranial Hypertension / drug therapy,  etiology
Isoantibodies / blood
Male
Middle Aged
Pregnancy
Recombinant Proteins / therapeutic use,  toxicity
Treatment Outcome
Chemical
Reg. No./Substance:
0/Isoantibodies; 0/Recombinant Proteins; 9001-27-8/Factor VIII; 9001-28-9/Factor IX; EC 3.4.21.21/Factor VIIa

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


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