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NCT04798014 · ClinicalTrials.gov registry record
HERO-2: Home-Reported Outcomes With CFTR Modulator Therapy
A clinical trial of Cystic Fibrosis, sponsored by Indiana University.
- Completed
- Registry status
- 860
- Enrollment target
- 1
- Study location
NCT04798014: Completed study of Cystic Fibrosis, sponsored by Indiana University.
NCT04798014 is a study of Cystic Fibrosis that has completed, run by Indiana University. The registered enrollment target is 860 participants, above the 174-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (394% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04798014, a study of Cystic Fibrosis, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- 860 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an observational cohort study, using data from Folia Health and the Cystic Fibrosis Foundation Patient Registry (CFFPR). Individuals taking elexacaftor/tezacaftor/ivacaftor (ETI) may be enrolled through the Folia application. During the 12-month study period, participants will be asked to track their routine treatment and medication usage, daily symptoms, and monthly review with validated patient-reported outcome (PRO) questionnaires. Participants will also be asked to self-report instances of changes to their treatment plan, and pulmonary exacerbations. There are no study-associated site visits.
Primary Outcome
The primary outcome measure of this study is change in FEV1 percent predicted at 12 months.
Conditions Studied
Study Locations (1)
Indiana
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 860 participants |
| Start Date | 2021-05-26 |
| Est. Completion | 2023-08-15 |
What the finished NCT04798014 record still lists
NCT04798014 is an observational study that tracks outcomes without assigning an intervention. The registered 860 participants enrollment target is mid-sized for trials with a published cap, above the 174-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (394% higher).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 0 interventions.
NCT04798014 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT04798014 about?
NCT04798014 is a clinical study titled "HERO-2: Home-Reported Outcomes With CFTR Modulator Therapy". This is an observational cohort study, using data from Folia Health and the Cystic Fibrosis Foundation Patient Registry (CFFPR). Individuals taking elexacaftor/tezacaftor/ivacaftor (ETI) may be enrolled through the Folia application. During the 12-month study period, participants will be asked to tr...
What is the current status of trial NCT04798014?
This trial is currently completed. The enrollment target is 860 participants. The study started on 2021-05-26. Estimated completion is 2023-08-15.
What conditions does trial NCT04798014 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
Who is sponsoring clinical trial NCT04798014?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04798014 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
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Where NCT04798014's enrollment target sits among peer trials
860 5th of 169 higher than 165 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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