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Amino Acid
L-Citrulline for Bronchopulmonary Dysplasia
Phase < 1
Waitlist Available
Led By Candice Fike, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
4.Hemoglobin > 10 mg/dL
Infants born prematurely at < or = 28 weeks gestation requiring invasive (mechanical ventilation) or non-invasive positive pressure support (nasal continuous positive airway pressure, high flow nasal cannula >1 lpm) and FiO2 of at least 0.30 at 32 +/- 1 weeks postmenstrual age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
Study Summary
This trial is to study if L-citrulline can help improve the chronic lung disease, bronchopulmonary dysplasia, in very low birth weight infants.
Eligible Conditions
- Bronchopulmonary Dysplasia
- Pulmonary Hypertension
- Premature Infants
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate ability to achieve target trough L-citrulline plasma level
Evaluate incidence of feedings being stopped following L-citrulline administration
Evaluate incidence of hypotension developing following L-citrulline administration
+1 moreSecondary outcome measures
Urinary nitrite and nitrate levels will be measured in subjects enrolled into Group 3.
Side effects data
From 2021 Phase 2 trial • 65 Patients • NCT045703849%
Infusion Site Reaction
6%
Deep Vein Thrombosis
6%
Dyspnoea
6%
Clostridium Difficile Infection
6%
Urinary Tract Infection
3%
Staphylococcal Sepsis; Alpha Haemolytic Streptococcal Infection
3%
Pain In Extremity
3%
Skin Wound
3%
Acute kidney injury
3%
Cardiac failure; metabolic acidosis
3%
Chest pain; Dyspnoea; COVID-19
3%
Intracranial hemorrhage
3%
Acute Myocardial Infarction
3%
Status epilepticus
3%
Syncope
3%
Enterococcal Infection
3%
Enterococcus Test Positive
3%
Epistaxis
3%
Hypoglycaemia
3%
Hypoxia
3%
Tachycardia
3%
Ventricular Extrasystoles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Arm
IV L-Citrulline (Turnobi) Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Steady-stateExperimental Treatment1 Intervention
To evaluate the tolerability and ability to achieve target trough L-citrulline levels of 100-150 µM, an additional group of 18 infants (group 3) will be given oral L-citrulline doses at intervals over a total of 72 hours. If the participant is not nipple feeding, the dose will be delivered via the participant's indwelling gavage feeding tube. The dose and interval of L-citrulline will be based on results from the studies that assess pharmacokinetic parameters using a maximum daily dose of 3 g/kg/d. Blood draws for PKs will be done at baseline and prior to last dose of L-citrulline. Urine will be collected to measure nitric oxide metabolites.
Group II: Single-doseExperimental Treatment1 Intervention
Participants will be enrolled into the two groups, Group 1 (which will consist of 10 participants) and Group 2 (which will consist of 8 participants) in an alternating basis. Both Group 1 and Group 2 participants will receive a single, 150 mg/kg dose of oral L-citrulline. Population PKs will be done for both groups, at up to 3 time points.
Multiple interim time points and following completion of enrollment into Groups 1 and 2, data analysis will be done and results reviewed by the data safety monitoring board (DSMB). After the DSMB review is complete, enrollment into Group 3 will begin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-Citrulline
2023
Completed Phase 2
~340
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,088 Previous Clinical Trials
1,728,333 Total Patients Enrolled
4 Trials studying Bronchopulmonary Dysplasia
100 Patients Enrolled for Bronchopulmonary Dysplasia
Candice Fike, MDPrincipal Investigator - University of Utah
University of Utah
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