A Study Evaluating the Efficacy and Safety of IV 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
Reason given: Interim Analysis triggered futility
Key facts
- Where
- Aurora, Birmingham, Chicago, Cincinnati, Columbus, Durham, Indianapolis, Madison, Seattle, and St Louis, United StatesSee the 10 sites
- Phase
- Phase 3
Where in United States
- Children's Hospital of ColoradoAurora, United StatesNo longer taking part
- Children's of AlabamaBirmingham, United StatesNo longer taking part
- Heart Center, Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, United StatesNo longer taking part
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesNo longer taking part
- Nationwide Children's Hospital- The Heart CenterColumbus, United StatesNo longer taking part
- Duke University Medical Center Surgical Office of Clinical Research (SOCR)Durham, United StatesNo longer taking part
- Riley Hospital for Children at Indiana University HealthIndianapolis, United StatesNo longer taking part
- University of Wisconsin - MadisonMadison, United StatesNo longer taking part
- Seattle Children's Research InstituteSeattle, United StatesNo longer taking part
- Cardinal Glennon Children's HospitalSt Louis, United StatesNo longer taking part
Trial details
- Who runs it
- Asklepion Pharmaceuticals, LLC
- Trial code
- NCT05253209
- Record updated
- 19 September 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Presence of fixed or idiopathic pulmonary hypertension (i.e. Eisenmenger's Syndrome) prior to surgical repair; 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; Pre-operative use of medications to treat pulmonary hypertension; Any condition which, in the opinion of the investigator, might interfere with the study objectives; Preoperative requirement for mechanical ventilation or IV inotrope support.