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news.Gentium, a biopharmaceutical company, has completed patient enrollment in a Phase II/III European, multi-center, open label, randomized trial to evaluate the prophylactic use of defibrotide in pediatric patients undergoing stem cell transplantation who are at high risk for hepatic veno-occlusive disease.
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In the Phase II/III trial, patients are randomly assigned to one of two treatment arms. Those allocated to the defibrotide prophylaxis arm receive 25mg/kg/day in four divided doses beginning at the time of conditioning and finishing 30 days after stem cell transplantation (SCT) or upon discharge from inpatient care.
Patients allocated to the control arm do not receive veno-occlusive disease (VOD) prophylactic measures. The primary efficacy endpoint for the trial is the incidence of VOD within 30 days after SCT. The secondary safety endpoints include the occurrence of multi-system organ failure and survival at 100 days after SCT. Gentium plans to release initial results of this trial by April 1, 2009.
Laura Ferro, CEO of Gentium, said: We are excited to have completed enrollment in our European Phase II/III prophylaxis trial for defibrotide in pediatric patients. Prior investigator sponsored trials for defibrotide in the prevention setting have shown promising results, and we are hopeful that this trial will fall in line with what we have previously seen.