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

CIT-CPB-003-02

This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible 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.

2022-06-29

2023-12-31

2024-02-10

Recruiting

Early phase I

97

Inclusion Criteria: * Patients, parents, or legal guardian willing and able to sign informed consent * Male and female subjects aged ≤18 years of age (females of child-bearing potential willing to practice an acceptable form of birth control) * Patients undergoing cardiopulmonary bypass for repair of a large unrestrictive ventricular septal defect, an ostium primum/secundum atrial septal defect, or a partial or complete atrioventricular septal defect * Pre-operative echocardiogram confirming cardiovascular anatomy and defect to be repaired Exclusion Criteria: * Evidence of pulmonary artery or vein abnormalities that will not be addressed surgically. Specific abnormalities excluded include: * significant pulmonary artery narrowing not amenable to surgical correction * previous pulmonary artery stent placement * significant left sided AV valve regurgitation not amenable to surgical correction * pulmonary venous return abnormalities not amenable to surgical correction * pulmonary vein stenosis not amenable to surgical correction * Preoperative requirement for mechanical ventilation or IV inotrope support * Presence of fixed or idiopathic pulmonary hypertension (i.e. Eisenmenger's Syndrome) prior to surgical repair * Pre-operative use of medications to treat pulmonary hypertension * Pregnancy; Sexually active females of child-bearing potential must be willing to practice an acceptable method of birth control for the duration of study participation (e.g. oral contraceptive, hormonal implant, intra-uterine device) * Participation in another clinical trial within 30 days of Screening or while participating in the current study, including the 28 days of follow-up post study drug administration. * Any condition which, in the opinion of the investigator, might interfere with the study objectives

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Randomization via an IWRS. Study drug or placebo will be prepared and labeled with the appropriate subject identifiers only; no information that would reveal the contents of the dose to be administered (active versus placebo) will be included on the label. Study drug (citrulline or placebo) will be provided in either identical syringes or bags and mask labeled. The bags will be the same size, shape, and fluid clarity, and hence masked to both investigators and staff administering the drug. Only the pharmacist and the unblinded monitor responsible for performing drug accountability (a different monitor than the person performing routine data monitoring) will be aware of the treatment assignment.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 97, 'type': 'ESTIMATED'}}

2023-08-21