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NCT03865927 · ClinicalTrials.gov registry record · Phase 2
GKT137831 in IPF Patients with Idiopathic Pulmonary Fibrosis
A Phase 2 study of Idiopathic Pulmonary Fibrosis, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 4
- Study locations
NCT03865927: Completed Phase 2 study of Idiopathic Pulmonary Fibrosis, sponsored by University of Alabama at Birmingham.
NCT03865927 is a Phase 2 study of Idiopathic Pulmonary Fibrosis that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 58 participants, below the 750-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03865927, a Phase 2 study of Idiopathic Pulmonary Fibrosis, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 4
- Study locations
Study Summary
A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients with idiopathic pulmonary fibrosis. This drug is an inhibitor of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (NOX) isoforms. The investigators hypothesize the drug will decrease pulmonary injury due to reactive oxygen species (ROS) generated by NOX enzymes, which are believed to play an important role in the development of IPF. Treatment with GKT137831 could result in significant benefit for a lung disease that has, until now, been almost invariably inexorable. This clinical trial represents the bedside application of a series of NOX translational and basic studies and discoveries, over several years, from the laboratory of Dr. Victor Thannickal.
Primary Outcome
Changes in concentrations of circulating o,o'-dityrosine, as determined by mass spectroscopy in plasma, in terms of absolute concentrations and percentages of baseline, will be compared within and between treatment arm participants.
Conditions Studied
Interventions
- OTHER Placebo Oral Tablet
- DRUG GKT137831
Study Locations (4)
Alabama
- University of Alabama at Birmingham - Birmingham
Louisiana
- Tulane University Medical Center - New Orleans
Michigan
- University of Michigan Medical Center - Ann Arbor
Pennsylvania
- Temple University Medical Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-09-07 |
| Est. Completion | 2024-11-30 |
| Phase | Phase 2 |
What the finished NCT03865927 record still lists
NCT03865927 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 750-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03865927 reports a single indexed study location in Alabama, Louisiana, Michigan.
Frequently Asked Questions
What is clinical trial NCT03865927 about?
NCT03865927 is a clinical study titled "GKT137831 in IPF Patients with Idiopathic Pulmonary Fibrosis". A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients with idiopathic pulmonary fibrosis. This drug is an inhibitor of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (NOX) isoforms. The investigators hypothesize the drug will decrease pulmonary inj...
What is the current status of trial NCT03865927?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2020-09-07. Estimated completion is 2024-11-30.
What conditions does trial NCT03865927 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis.
What interventions are being tested in trial NCT03865927?
The interventions under investigation include: Placebo Oral Tablet (OTHER), GKT137831 (DRUG).
Who is sponsoring clinical trial NCT03865927?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03865927 being conducted?
This trial has 4 study locations across Alabama, Louisiana, Michigan, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Idiopathic Pulmonary Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03865927's enrollment target sits among peer trials
58 29th of 51 higher than 22 of 51 other Idiopathic Pulmonary Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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