Safety and efficacy of a new recombinant FVIII formulated with sucrose (fFVIII-FS) in patients with haemophilia A: A long-term, multicentre clinical study in Japan

Haemophilia

Volumn 7, Issue 3, 2001, Pages 242-249

  Yoshioka, A ^a,b,e   Shima, M ^a,b   Fukutake, K ^a,c   Takamatsu, J ^a,c   Shirahata, A ^a,d   Saito, Yoshiko ^f   Ishikawa, Masaaki ^f   Arai, Morio ^b   Suzuki, Takashi ^b   Hanabusa, Hideji ^g   Sasaki, Nozomu ^h   Shibuya, Atsushi ^h   Taki, Masashi ⁱ   Shimizu, Hironobu ⁱ   Den, Miwako ⁱ   Mimaya, Junichi ^j   Kojima, Tetsuhito ^c   Ogata, Kanji ^k   Tanaka, Ichiro ^a   Ikari, Hisao ^l   Kinoshita, Seiji ^m   Kakishita, Eizo ⁿ   Higasa, Satoshi ⁿ   Kurihara, Kiyoshi ^d   Kamizono, Junji ^d   more..

^a NARA MEDICAL UNIVERSITY   (Japan)

^b TOKYO MEDICAL UNIVERSITY   (Japan)

^c NAGOYA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^e Ogikubo Hospital ^*  (Japan)

^f TOHOKU UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^g Ogikubo Hospital   (Japan)

^h SAITAMA MEDICAL UNIVERSITY   (Japan)

ⁱ ST MARIANNA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^j SHIZUOKA CHILDREN'S HOSPITAL   (Japan)

^k Aichi Sannomaru Hospital   (Japan)

^l National Senboku Hospital   (Japan)

^m Higashiosaka City General Hospital   (Japan)

ⁿ HYOGO COLLEGE OF MEDICINE   (Japan)

more..

Author keywords

Haemophilia A; Haemostatic effect; In vivo recovery; Recombinant factor VIII; RFVIII FS

Indexed keywords

BLOOD CLOTTING FACTOR 8 ANTIBODY; BLOOD CLOTTING FACTOR 8 INHIBITOR; CD4 ANTIGEN; CD8 ANTIGEN; HUMAN SERUM ALBUMIN; IMMUNOGLOBULIN G; RECOMBINANT BLOOD CLOTTING FACTOR 8; STABILIZING AGENT; SUCROSE;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION; ANALYSIS; ARTICLE; BLEEDING; CELL STRAIN BHK; CHILD; CLINICAL ARTICLE; CLINICAL STUDY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; DRUG FORMULATION; DRUG INFUSION; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; EPIDEMIOLOGY; HEMOPHILIA A; HEMOSTASIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; IN VIVO STUDY; JAPAN; LONG TERM CARE; MULTICENTER STUDY; PRIORITY JOURNAL; PURIFICATION; TIME;

ADOLESCENT; ADULT; CHILD; COHORT STUDIES; CONSUMER PRODUCT SAFETY; DRUG COMBINATIONS; FACTOR VIII; HEMOPHILIA A; HEMORRHAGE; HEMOSTASIS; HUMANS; ISOANTIBODIES; JAPAN; LONGITUDINAL STUDIES; MIDDLE AGED; RECOMBINANT PROTEINS; SUCROSE; THERAPEUTIC EQUIVALENCY;

EID: 6644228391     PISSN: 13518216     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2516.2001.00511.x     Document Type: Article

References (16)

1. Melbye M, Froebel KS, Madhok R et al. HTLV-III seropositivity in European haemophiliacs exposed to factor Vin concentrate imported from the USA. Lancet 1984; 2: 1444-6.
2. Pierce GF, Lusher JM, Brownstein SP, Goldsmith JC, Kessler CM. The use of purified clotting factor concentrates in hemophilia: influence of viral safety, cost and supply on therapy. JAMA 1989; 261: 3434-8.
3. Brettler DB, Levine PH. Factor concentrates for treatment of hemophilia: which one to choose? Blood 1989; 73: 2067-73.
4. Fukui H, Yoshioka A, Shima M et al. Clinical evaluation of recombinant human factor VIII (BAY w 6240) in the treatment of hemophilia A. Int J Hematol 1991; 54: 419-27.
5. Fukui H, Mori K, Ishikawa M et al. A long-term, multi-center clinical study of recombinant human factor VIII (BAY w 6240) in treatment of hemophilia A. Jpn J Transfus Med 1991; 37: 593-604 (in Japanese with English abstract).
6. Seremetis S, Lusher JM, Abildgaard CF et al. Human recombinant DNA-derived antihaemophilic factor (factor VIII) in the treatment of haemophilia A. conclusions of a 5-year study of home therapy. Haemophilia 1999; 5: 9-16.
7. Ludlam CA. New-variant Creutzfeldt-Jakob disease and treatment of haemophilia. Lancet 1997; 350: 1704.
8. Mannucci PM, Gdovin S, Gringeri A et al. Transmission of hepatitis A to patients with hemophilia by factor VIII concentrates treated with organic solvent and detergent to inactivate viruses. Ann Int Med 1994; 120: 1-7.
9. Lawlor E, Johnson Z, Thornton L, Temperley I. Investigation of an outbreak of hepatitis A in Irish haemophilia A patients. Vox Sang 1994; 67 (Suppl. 1): 18-20.
10. Centers for Disease Control. Hepatitis A among persons with hemophilia who received clotting factor concentrate - United States, September-December 1995. Morbid Mortal Weekly Rep 1996; 45: 29-32.
11. Hoots K, Lusher JM, Manco-Johnson M et al. Phase I pharmacokinetic crossover trial of recombinant FVIII and a new sucrose-formulated recombinant FVIII. Haemophilia 1998; 4: 189.
12. Brackmann HH, Abshire T, Scharrer I et al. Safety and efficacy of a sucrose-formulated recombinant factor VIII (rFVIII-SF) during home treatment of patients with severe hemophilia A. Haemophilia 1998; 4: 190.
13. Brackmann HH, Abshire T, Scharrer I et al. A multi-center, international clinical trial on safety and efficacy of sucrose-formulated recombinant factor VIII for treatment of hemophilia A. Thromb Haemost 1999; 82 (Suppl.): 472.
14. Abshire TC, Brackmann HH, Scharrer I et al. Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy. Thromb Haemost 2000; 83: 811-6.
15. Shirahata A, Fukutake K, Takamatsu J, Shima M, Yoshioka A. Pharmacokinetic, prophylactic effects and safety of a new recombinant FVIII formulated with sucrose (BAY 14-2222) in Japanese patients with hemophilia A. Int J Hematol 2000; 72: 101-7.
16. Kasper CK, Aledort LM, Counts RB et al. A more uniform measurement of factor VIII inhibitors. Thromb Diath Haemorrh 1975; 34: 869-72.