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NCT04901715 · ClinicalTrials.gov registry record · Early Phase 1

Functional Studies of Novel Genes Mutated in Primary Ciliary Dyskinesia II: Genotype to Phenotype

A Early Phase 1 study of Primary Ciliary Dyskinesia, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Early Phase 1
Development phase
27
Enrollment target
1
Study location

NCT04901715 is a Early Phase 1 study of Primary Ciliary Dyskinesia that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 27 participants, below the 106-participant average among 7 other Primary Ciliary Dyskinesia trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04901715, a Early Phase 1 study of Primary Ciliary Dyskinesia, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Early Phase 1
Development phase
27 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to measure mucociliary clearance (MCC) in groups of subjects with the disease Primary Ciliary Dyskinesia (PCD) caused by mutations in different genes, and compare to healthy subjects. Some of these genes are associated with a milder clinical phenotype. This study seeks to determine if the milder phenotype is a result of mutations in a set of specific genes. The hypothesis is that subjects with PCD caused by mutations in the milder group will maintain a low, but significant rate of mucociliary clearance, while patients with mutations in genes in the more severe group will have a complete absence of mucociliary clearance. These studies will help inform future treatment strategies.

Conditions Studied

Interventions

  • DRUG Albuterol
  • DIAGNOSTIC_TEST Technetium99m - Sulfur Colloid (Tc99m-SC)

Study Locations (1)

North Carolina

  • University of North Carolina Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2021-06-10
Est. Completion 2024-07-22
Phase Early Phase 1

What the Registry Record Tells You About NCT04901715

The ClinicalTrials.gov registry entry for NCT04901715 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 106-participant average among 7 other Primary Ciliary Dyskinesia trials with a reported enrollment target (75% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Primary Ciliary Dyskinesia appearing as the primary indexed condition, and to 2 interventions - of which Albuterol is the first listed.

NCT04901715 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT04901715 about?

NCT04901715 is a clinical study titled "Functional Studies of Novel Genes Mutated in Primary Ciliary Dyskinesia II: Genotype to Phenotype". The purpose of this study is to measure mucociliary clearance (MCC) in groups of subjects with the disease Primary Ciliary Dyskinesia (PCD) caused by mutations in different genes, and compare to healthy subjects. Some of these genes are associated with a milder clinical phenotype. This study seeks t...

What is the current status of trial NCT04901715?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 27 participants. The study started on 2021-06-10. Estimated completion is 2024-07-22.

What conditions does trial NCT04901715 study?

This clinical trial studies the following conditions: Primary Ciliary Dyskinesia.

What interventions are being tested in trial NCT04901715?

The interventions under investigation include: Albuterol (DRUG), Technetium99m - Sulfur Colloid (Tc99m-SC) (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04901715?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04901715 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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