|Recombinant factor VIIa for patients with inhibitors to factor VIII or IX or factor VII deficiency.|
|PMID: 10469179 Owner: NLM Status: MEDLINE|
|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.|
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|Type: Clinical Trial; Controlled Clinical Trial; Journal Article; Multicenter Study|
|Title: Haemophilia : the official journal of the World Federation of Hemophilia Volume: 5 ISSN: 1351-8216 ISO Abbreviation: Haemophilia Publication Date: 1999 Jul|
|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|
|Languages: eng Pagination: 253-9 Citation Subset: IM|
|Klinikum der Johann Wolfgang Goethe-Universität, Zentrum der Inneren Medizin, Frankfurt am Main, Germany.|
|APA/MLA Format Download EndNote Download BibTex|
Blood Loss, Surgical / prevention & control
Factor IX / immunology, therapeutic use
Factor VII Deficiency / drug therapy
Factor VIII / immunology, therapeutic use
Factor VIIa / standards, therapeutic use*, toxicity
Gastrointestinal Hemorrhage / drug therapy, etiology
Hemarthrosis / drug therapy, etiology
Hemophilia A / complications, drug therapy, immunology
Hemophilia B / complications, drug therapy, immunology
Hemorrhage / drug therapy
Intracranial Hemorrhages / drug therapy, etiology
Intracranial Hypertension / drug therapy, etiology
Isoantibodies / blood
Recombinant Proteins / therapeutic use, toxicity
|0/Isoantibodies; 0/Recombinant Proteins; 9001-27-8/Factor VIII; 9001-28-9/Factor IX; EC 126.96.36.199/Factor VIIa|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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