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NCT04509050 · ClinicalTrials.gov registry record
Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children
A clinical trial of Cystic Fibrosis, sponsored by Sonya Heltshe.
- Recruiting
- Registry status
- 210
- Enrollment target
- 20
- Study locations
NCT04509050 is a study of Cystic Fibrosis that is actively recruiting participants, run by Sonya Heltshe. The registered enrollment target is 210 participants, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (18% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT04509050, a study of Cystic Fibrosis, is actively recruiting participants, sponsored by Sonya Heltshe.
- RECRUITING
- Registry status
- 210 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF).
Conditions Studied
Interventions
- DRUG Ivacaftor or elexacaftor/tezacaftor/ivacaftor
Study Locations (20)
New York
- The Cystic Fibrosis Center of Western New York - Buffalo
- Children's Hospital of New York - New York
- SUNY Upstate Medical University - Syracuse
- New York Medical College at Westchester Medical Center - Valhalla
Florida
- Nemours Children's Clinic - Jacksonville
- University of Miami - Miami
- The Nemours Children's Clinic - Orlando - Orlando
Michigan
- University of Michigan, Michigan Medicine - Ann Arbor
- Helen DeVos Children's Hospital - Grand Rapids
Minnesota
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- The Minnesota Cystic Fibrosis Center - Minneapolis
Missouri
- Children's Mercy Kansas City - Kansas City
- St. Louis Children's Hospital - St Louis
Alabama
- The Children's Hospital Alabama, University of Alabama at Birmingham - Birmingham
California
- Stanford University Medical Center - Palo Alto
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2020-11-18 |
| Est. Completion | 2029-12-01 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04509050
The ClinicalTrials.gov registry entry for NCT04509050 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (18% higher). The listed sponsor is Sonya Heltshe, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Ivacaftor or elexacaftor/tezacaftor/ivacaftor is the first listed.
NCT04509050 reports 20 study locations spanning 12 distinct geographic areas - top geographies include New York, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT04509050 about?
NCT04509050 is a clinical study titled "Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children". This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF).
What is the current status of trial NCT04509050?
This trial is currently recruiting. The enrollment target is 210 participants. The study started on 2020-11-18. Estimated completion is 2029-12-01.
What conditions does trial NCT04509050 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT04509050?
The interventions under investigation include: Ivacaftor or elexacaftor/tezacaftor/ivacaftor (DRUG).
Who is sponsoring clinical trial NCT04509050?
This trial is sponsored by Sonya Heltshe, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04509050 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.