Chronic Anemia
FDA concurs with Vitex pivotal phase III Inactine red blood cell program
Published in Blood Weekly, August 8th, 2002
V.I. Technologies, Inc., (Vitex) (VITX) announced that it has reached written agreement with the Food and Drug Administration (FDA) to initiate its pivotal phase III clinical trial program with the INACTINE pathogen reduction red blood cell system. The key pivotal program highlights include: Two phase III studies: An evaluation of safety and effectiveness of red blood cells in a study with patients requiring acute transfusion support and in a second study with patients requiring chronic transfusion support. Trial Size: The two studies are expected to enroll approximately 270 patients combined. Trial Design: Both studies are designed as multicenter,...
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Source: Blood Weekly (2002-08-08)
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