A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor: The FEIBA NovoSeven Comparative (FENOC) study

Blood

Volumn 109, Issue 2, 2007, Pages 546-551

  Astermark, Jan ^a   Donfield, Sharyne M ^b   DiMichele, Donna M ^c   Gringeri, Alessandro ^d   Gilbert, Steven A ^b   Waters, Jennifer ^b   Berntorp, Erik ^a  

^a LUND UNIVERSITY HOSPITAL   (Sweden)

^b RHO INC   (United States)

^c WEILL CORNELL MEDICAL COLLEGE   (United States)

^d UNIVERSITY OF MILAN   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ACTIVATED PROTHROMBIN COMPLEX; RECOMBINANT BLOOD CLOTTING FACTOR 7A;

ABSENCE OF SIDE EFFECTS; ADOLESCENT; ADULT; ARTICLE; BODY REGIONS; CHILD; CLINICAL EVALUATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG EFFICACY; DRUG INFUSION; GEOGRAPHIC DISTRIBUTION; HEMARTHROSIS; HEMOPHILIA; HEMOSTASIS; HUMAN; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TREATMENT OUTCOME;

EID: 33846185403     PISSN: 00064971     EISSN: 00064971     Source Type: Journal    
DOI: 10.1182/blood-2006-04-017988     Document Type: Article

References (20)

1. Wight J, Paisley S. The epidemiology of inhibitors in haemophilia A: a systematic review. Haemophilia. 2003;9:418-435.
2. DiMichele DM. Immune tolerance: a synopsis of international experience. Haemophilia. 1998;4:568-573.
3. Wight J, Paisley S, Knight C. Immune tolerance induction in patients with hemophilia A with inhibitors: a systematic review. Haemophilia. 2003;9:436-463.
4. Lloyd Jones M, Wight J, Paisley S, Knight C. Control of bleeding in patients with hemophilia A with inhibitors: a systematic review. Haemophilia. 2003;9:464-520.
5. Astermark J. Treatment of the bleeding inhibitor patient. Semin Thromb Hemost. 2003;29:77-86.
6. Sjamsoedin LJ, Heijnen L, Mauser-Bunschoten EP, et al. The effect of activated prothrombin-complex concentrate (FEIBA) on joint and muscle bleeding in patients with hemophilia A and antibodies to factor VIII. A double-blind clinical trial. N Engl J Med. 1981;305:717-721.
7. Hedner U, Glazer S, Pingel K, et al. Successful use of recombinant factor VIIa in patients with severe hemophilia A during synovectomy. Lancet. 1988;2:1193.
8. Lusher J, Ingerslev J, Roberts H, Hedner U. Clinical experience with recombinant factor VIIa. Blood Coagul Fibrinolysis. 1998;9:119-128.
9. Turecek PL, Varadi K, Gritsch H, Schwarz HP. FEIBA: mode of action. Haemophilia. 2004;10(suppl 2):3-9.
10. Hoffman M, Monroe DM III. The action of high-dose factor VIIa (FVIIa) in a cell-based model of hemostasis. Dis Mon. 2003;49:14-21.
11. Negrier C, Goudemand J, Sultan Y, Bertrand M, Rothschild C, Lauroua P, and the members of the French FEIBA study group. Multicenter retrospective study on the utilization of FEIBA in France in patients with factor VIII and factor IX inhibitors. Thromb Haemost. 1997;77:1113-1119.
12. Key NS, Aledort LM, Beardsley D, et al. Home treatment of mild to moderate bleeding episodes using recombinant factor VIIa (NovoSeven) in haemophiliacs with inhibitors. Thromb Haemost. 1998;80:912-918.
13. Parameswaran R, Shapiro AD, Gill JC, Kessler CM; HTRS Registry Investigators. Dose effect and efficacy of rFVIIa in the treatment of haemophilia patients with inhibitors: analysis from the Hemophilia and Thrombosis Research Society Registry. Haemophilia. 2005;11:100-106.
14. Lee ML, Lusher JM. The problem of therapeutic equivalence with paired qualitative data: an example from a clinical trial using haemophiliacs with an inhibitor to factor VIII. Stat Med. 1991;10:433-441.
15. Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73:13-22.
16. Hooiveld MJ, Roosendaal G, van den Berg HM, Bijlsma JW, Lafeber FP. Haemoglobin-derived iron-dependent hydroxyl radical formation in blood-induced joint damage: an in vitro study. Rheumatology (Oxford). 2003;42:784-790.
17. Hilgartner MH, Knatterud GL. The use of factor eight inhibitor by-passing activity (FEIBA immuno) product for treatment of bleeding episodes in hemophiliacs with inhibitors. Blood. 1983;61:36-40.
18. Astermark J, Ekman M, Berntorp E. Antibodies to factor VIIa in patients with haemophilia and high-responding inhibitors. Br J Haematol. 2002;119:342-347.
19. Lusher JM. Acute hemarthroses: the benefits of early versus late treatment with recombinant activated factor VII. Blood Coagul Fibrinolysis. 2000;11(suppl 1):S45-S49.
20. Hooiveld MJ, Roosendaal G, Jacobs KM, et al. Initiation of degenerative joint damage by experimental bleeding combined with loading of the joint: a possible mechanism of hemophilic arthropathy. Arthritis Rheum. 2004;50:2024-2031.