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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 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.

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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.

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

FieldValue
Enrollment Target 58 participants
Start Date 2020-09-07
Est. Completion 2024-11-30
Phase Phase 2

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT03865927

The ClinicalTrials.gov registry entry for NCT03865927 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 750-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (92% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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