NCT05253209 is a Phase 3 clinical trial of L-citrulline in Ventricular Septal Defect, sponsored by Asklepion Pharmaceuticals, LLC.

Who is sponsoring NCT05253209?

NCT05253209 is sponsored by Asklepion Pharmaceuticals, LLC.

What drugs are being tested in NCT05253209?

Interventions in NCT05253209: L-citrulline, Plasmalyte A.

What condition does NCT05253209 study?

NCT05253209 studies Ventricular Septal Defect, Atrioventricular Septal Defect, Primum Atrial Septal Defect.

Is NCT05253209 still recruiting?

NCT05253209 is currently terminated. Last updated 19 September 2024.

Last reviewed 2024-09-19 · How we verify

NCT05253209

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 3 Last updated 19 September 2024

What this trial tests

Phase 3 trial testing L-citrulline in Ventricular Septal Defect in 64 participants. Terminated before completion.

Timeline

29 June 2022

Primary endpoint
10 May 2024

10 May 2024

Quick facts

Lead sponsor	Asklepion Pharmaceuticals, LLC
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	64
Start date	29 June 2022
Primary completion	10 May 2024
Estimated completion	10 May 2024
Sites	10 locations across United States

Drugs / interventions tested

L-citrulline (Citrulline) — full drug profile →
Plasmalyte A — full drug profile →

Conditions studied

Ventricular Septal Defect — all drugs for Ventricular Septal Defect →
Atrioventricular Septal Defect — all drugs for Atrioventricular Septal Defect →
Primum Atrial Septal Defect — all drugs for Primum Atrial Septal Defect →

Sponsor

Asklepion Pharmaceuticals, LLC — full company profile →

Who can join

Under 18, any sex, with Ventricular Septal Defect or Atrioventricular Septal Defect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The molecular mechanisms of cardiac development and related diseases.
Li Y, Du J, Deng S, Liu B, et al · · 2024 · cited 53× · PMID 39715759 · DOI 10.1038/s41392-024-02069-8

Verify or expand the search:

Other trials of L-citrulline

Trials testing the same drug.

NCT06426147 — L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients) · NA · recruiting
NCT06212765 — Oral Citrulline Supplementation in COPD Patients With Malnutrition · Phase 3 · not yet recruiting
NCT05934318 — L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) · NA · recruiting
NCT06016478 — The Effect of 4 Weeks of L-Citrulline Supplementation on Macro- and Microvascular Function in Type 2 Diabetes · NA · completed
NCT05778266 — Effect of L-citrulline and HIIT on Arterial Stiffness, Body Composition, and Lipid Profile in Adolescents with Steatosis · NA · completed

Other recruiting trials for Ventricular Septal Defect

Currently open trials in the same condition.

NCT06676345 — Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study · recruiting
NCT06492473 — Clinical Evaluation Of Ventricular Septal Defect (VSD) In Children at Sohag Univesity Hospital · recruiting

Other Asklepion Pharmaceuticals, LLC trials

Trials by the same sponsor.

NCT04852172 — L-citrulline Injection in Patients Aged 6-21 Years Old with Sickle Cell Disease Presenting with Vaso-Occlusive Crisis (V · Phase 1, PHASE2 · terminated
NCT04570384 — Intravenous L-Citrulline Influence on the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failu · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05253209 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Asklepion Pharmaceuticals, LLC
Last refreshed: 19 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05253209.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing