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NCT04613128 · ClinicalTrials.gov registry record
The PROMISE Pediatric Study 6 to 11 Years Old
A clinical trial of Cystic Fibrosis and Cystic Fibrosis in Children, sponsored by Nicole Hamblett.
- Active
- Registry status
- 180
- Enrollment target
- 20
- Study locations
NCT04613128: Active study of Cystic Fibrosis and Cystic Fibrosis in Children, sponsored by Nicole Hamblett.
NCT04613128 is a study of Cystic Fibrosis and Cystic Fibrosis in Children that is active but no longer recruiting, run by Nicole Hamblett. The registered enrollment target is 180 participants, roughly in line with the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target. The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04613128, a study of Cystic Fibrosis and Cystic Fibrosis in Children, is active but no longer recruiting, sponsored by Nicole Hamblett.
- ACTIVE NOT RECRUITING
- Registry status
- 180 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, multi-center observational study. The study is designed to measure the clinical effectiveness of elexacaftor, tezacaftor and ivacaftor (ETI) triple combination therapy in children (6-11 years of old) with one or more copies of the F508del mutation, study the effects of ETI across a number of CF disease manifestations, and collect specimens for future research. Subjects in the study will have one "before ETI" visit within 30 days before initiation of the therapy and five "after ETI" visits over a 24-month follow-up period. Participants who have participated in the original PROMISE Pediatric Sub-Study have the option of participating in a long-term extension with annual visits performed at the 36- and 48-month timepoints. The durability of the clinical and biological changes in the PROMISE Pediatric Sub-Study can be assessed with extended follow-up, which would enable the sub-studies to consider potential clinical consequences of the biological or physiological effects being studied. This work will help to inform long term prognosis and feasibility of certain clinical trials outcomes for interventional studies and may be useful when considering research priorities in drug development. The duration of participation for each subject is 24 months (with an additional 24 months if participants agree to the optional long-term extension). NOTE: FDA has granted approval for elexacaftor, tezacaftor and ivacaftor in the 6-11 age group.
Primary Outcome
Change in sweat chloride from Baseline to 6 months.
Conditions Studied
Study Locations (20)
Missouri
- Children's Mercy Kansas City - Kansas City
- Washington University School of Medicine - St Louis
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center - Cleveland
Wisconsin
- University of Wisconsin - Madison
- Children's Hospital of Wisconsin - Milwaukee
Alabama
- University of Alabama at Birmingham - Birmingham
California
- Stanford University Medical Center - Palo Alto
Colorado
- Children's Hospital Colorado - Aurora
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2021-06-11 |
| Est. Completion | 2026-01-31 |
What the registry record for NCT04613128 still lists
NCT04613128 is an observational study that tracks outcomes without assigning an intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target.
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 0 interventions.
NCT04613128 names 20 study sites across 17 states, led by Missouri, Ohio, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04613128 about?
NCT04613128 is a clinical study titled "The PROMISE Pediatric Study 6 to 11 Years Old". This is a prospective, multi-center observational study. The study is designed to measure the clinical effectiveness of elexacaftor, tezacaftor and ivacaftor (ETI) triple combination therapy in children (6-11 years of old) with one or more copies of the F508del mutation, study the effects of ETI acr...
What is the current status of trial NCT04613128?
This trial is currently active not recruiting. The enrollment target is 180 participants. The study started on 2021-06-11. Estimated completion is 2026-01-31.
What conditions does trial NCT04613128 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Cystic Fibrosis in Children.
Who is sponsoring clinical trial NCT04613128?
This trial is sponsored by Nicole Hamblett, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04613128 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04613128's enrollment target sits among peer trials
180 38th of 169 higher than 132 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic 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.
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