Hemophilia replacement products, clinical trials: Inhibitors and pharmacokinetics - Can they be done? [3]

Journal of Thrombosis and Haemostasis

Volumn 2, Issue 10, 2004, Pages 1855-1856

  Aledort, Louis M ^a  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9; RECOMBINANT BLOOD CLOTTING FACTOR 8;

CLINICAL STUDY; CLINICAL TRIAL; DISEASE SEVERITY; DRUG EXPOSURE; DRUG RESPONSE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG USE; ETHNOLOGY; FOOD AND DRUG ADMINISTRATION; GENETICS; GERMANY; HEMOPHILIA; HUMAN; LETTER; LICENCE; MEDICAL LITERATURE; METHODOLOGY; MOLECULAR MODEL; NETHERLANDS; PATIENT MONITORING; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLISHING; RISK FACTOR; SUBSTITUTION THERAPY;

AUTOANTIBODIES; BLOOD COAGULATION FACTORS; CLINICAL TRIALS; HEMOPHILIA A; HUMANS; PHARMACOKINETICS; PRACTICE GUIDELINES;

EID: 13244281593     PISSN: 15387933     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1538-7836.2004.00911.x     Document Type: Letter

References (9)

1. Aledort L. Inhibitors in hemophilia patients: current status and management. Am J Hematol 1994; 47: 208-17.
2. White GC, DiMichele DM, Mertens K, Negrier C, Peake IR, Prowse C, Schwaab R, Yoshioka A, Ingerslev J. Utilitzation of previously treated patients (PTPs), noninfected patients (NIPs), and previously untreated patients (PUPs) in the evaluation of new Factor VIII and Factor IX concentrates. Thromb Haemost 1999; 81: 462.
3. McMillan CW, Shapiro SS, Whitehurst D, Hoyer LW, Rao AV, Lazerson J. The natural history of factor VIII:C inhibitors in patients with hemophilia A: a national cooperative study. II. Observations on the initial development of factor VIII:C inhibitors. Blood 1988; 71 344-8.
4. Addiego J, Kasper C, Abildgaard C, Hilgartner M, Lusher J. Inhibitors in factor VIII deficient hemophilia: comparison of frequency based upon treatment product. Blood 1992; 80: 231A.
5. Bray GL, Gomperts ED, Courter S, Gruppo R, Gordon EM, Manco-Johnson M, Shapiro A, Scheibel E, White G 3rd, Lee M. A multicenter study of recombinant factor VIII (Recombinate): safety, efficacy, and inhibitor risk in previously untreated patients with hemophilia A. Blood 1994; 83: 2428-35.
6. Schwartz RS, Abildgaard CF, Aledort LM, Arkin S, Bloom AL, Brackmann HH, Brettler DB, Fukui H, Hilgartner MW, Inwood MJ, Kasper CK, Kernoff PBA, Levine PH, Lusher JM, Mannucci PM, Scharrer I, MacKenzie MA, Pancham N, Kuo HS, Allred RU and the Recombinant Factor VIII Study Group. Human recombinant DNA-derived antihemophilic factor (factor VIII) in the treatment of hemophilia A. N Engl J Med 1990; 323: 1800-5.
7. Abshire TC, Brackmann HH, Scharrer I, Hoots K, Gazengel C, Powell JS, Gorina E, Kellermann E, Vosburgh E and the International Kogenate-FS Study Group. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy: results of a multicenter, international, clinical investigation. Thromb Haemost 2000; 83: 811-6.
8. Courter SG, Bedrosian CL. Clinical evaluation of B-domain deleted recombinant factor VIII in previously treated patients. Semin Hematol 2001; 38: 44-51.
9. Rosendaal FR, Nieuwenhuis HK, Van den Berg HM, Heijboer H, Mauser-Bunschoten EP, Van der Meer J, Smit C, Strengers PFW, Briët E, Dutch Hemophilia Study Group. A sudden increase in factor VIII inhibitor development in multitransfused hemophilia A patients in the Netherlands. Blood 1993; 81: 2180-6.