11 In a P2 trial, enteral administration of talactoferrin (recombinant human lactoferrin) improved survival of patients with severe sepsis and the treatment effect just missed being statistically significant ( P = 0.052). 12 Unfortunately, when the same drug was evaluated in a much larger P3 study, enrollment of patients was stopped early by the data safety monitoring board (DSMB) because of excess mortality in the talactoferrin-treated arm. 13 The first P3 study of recombinant human activated protein C yielded unequivocally positive results 14 and led to regulatory approval of the agent in North America and Europe.
1
0.0520
0.0520