A Phase III Double-Blind, Randomized, Placebo Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Intravenous L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects (Protocol CIT-CPB-003-02)
What is the goal of the study?
This is a randomized, double-blind, placebo controlled, multi-center study that will compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Patients undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment. Each enrolled patient will be randomized to receive either L-citrulline or placebo throughout all administrations in the study. Patients will be followed until Day 28 or discharge from the hospital, whichever comes first. For patients discharged prior to Day 28, a final assessment via telephone will be conducted at Day 28.
Who can participate in the study?
Please contact the study team listed below to learn more.