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NCT03542812 · ClinicalTrials.gov registry record · Early Phase 1
L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia
A Early Phase 1 study, sponsored by University of Utah.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
NCT03542812 is a Early Phase 1 study that was terminated before completion, run by University of Utah. The registered enrollment target is 16 participants.
The verdict
NCT03542812, a Early Phase 1 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects up to 35% of very low birth weight infants (VLBW \< 1500 g). Based on the current numbers of VLBW infants born annually in the U.S., between 5,000-10,000 neonates will develop BPD each year. It is estimated that 8-42% of infants with BPD will develop pulmonary hypertension (PH). Moreover, it has been known since the 1980's that echocardiographic evidence of PH in infants with BPD is associated with up to 40% mortality. Treatment options to ameliorate PH in infants with BPD (BPD-PH) are limited. There have been no randomized clinical trials of any therapy in infants with BPD-PH. The standard care for the management of BPD-PH is to attempt to resolve the underlying lung disorder and the judicious use of oxygen as a potent pulmonary vasodilator. Using this management approach, which has not changed since the 1980's, the survival rates for infants with BPD-PH in the 2000's has been reported to be 64% at 6 months and 53% at 2 years after diagnosis of PH. The lack of improvement in outcomes for the past 3 decades has led to the widespread agreement that novel and effective therapies are desperately needed for infants with BPD-PH. The goal is to develop oral L-citrulline clinically for the treatment of pediatric pulmonary hypertension associated with bronchopulmonary dysplasia (BPD-PH); before pursuing a large scale treatment trial, pharmacokinetic (PK) dose-finding, tolerability studies in patients at high risk of developing BPD-PH are warranted. The hypothesis is that oral L-citrulline will be well tolerated, without significant adverse effects in infants at high risk of developing pulmonary hypertension (PH) associated with BPD. The investigators propose to first characterize the PK profile of oral L-citrulline in order to define an appropriate dose range and treatment interval for infants at high risk of developing BPD-PH. Then using the doses and intervals generated by the PK profile, with a ma
Interventions
- DRUG L-Citrulline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-07-30 |
| Est. Completion | 2022-08-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03542812
The ClinicalTrials.gov registry entry for NCT03542812 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which L-Citrulline is the first listed.
NCT03542812 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03542812 about?
NCT03542812 is a clinical study titled "L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia". Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects up to 35% of very low birth weight infants (VLBW \< 1500 g). Based on the current numbers of VLBW infants born annually in the U.S., between 5,000-10,000 neonates will develop BPD each year. It is estimated that 8-42% of infants...
What is the current status of trial NCT03542812?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2019-07-30. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT03542812?
The interventions under investigation include: L-Citrulline (DRUG).
Who is sponsoring clinical trial NCT03542812?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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