Clinical efficacy of recombinant factor VIII. The rFactor VIII Clinical Trial Group.
This investigation has been an ongoing, multistage evaluation of the pharmacokinetics, safety and efficacy of a factor VIII concentrate prepared through recombinant DNA technology. In vivo activity of the rFVIII has been comparable to that of pdFVIII including half life and in vivo recovery. Recombinant factor VIII is safe and effective for prophylaxis and treatment of hemophilic bleeding episodes. Efficacy of rFVIII appears comparable with that of pdFVIII concentrates. Infusions were well tolerated with infrequent adverse reactions. As with any new product, the verdict regarding induction of inhibitors to factor VIII awaits evaluation of sufficient numbers of patients and passage of adequate observation time.
Arkin
S
S
University of California, Davis.
Rose
E
E
Forster
A
A
Aledort
L M
LM
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004341:Drug Evaluation; D005169:Factor VIII / Q000009:adverse effects / Q000627:therapeutic use*; D006467:Hemophilia A / Q000628:therapy*; D006801:Humans; D007430:Intraoperative Care; D008875:Middle Aged; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D013514:Surgical Procedures, Operative
D011993:Recombinant Fusion Proteins; D005169:Factor VIII