Recruitment setbacks for Ph III defibrotide trial

The Data Safety Monitoring Board review of a Phase III trial of Gentium's defibrotide for severe veno-occlusive disease has recommended increasing the number of patients so the results can achieve the statistical power for approval.

According to the Italian drugmaker, in order for the study to be 80% powered to detect a p-value of 0.01, the necessary statistical hurdle under the current protocol for US Food and Drug Administration approval, the sample size should be increased to 160 patients in the treatment arm and 80 subjects in the historical control arm.