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NCT03783286 · ClinicalTrials.gov registry record
Ivacaftor Treatment in 4 Month to 2 Year Old CF Subjects
A clinical trial, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- 15
- Enrollment target
NCT03783286: Completed study, sponsored by Children's Hospital of Philadelphia.
NCT03783286 is a clinical trial that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03783286 has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the effects of clinically prescribed ivacaftor treatment on 4-24 month old children with CF and gating mutations on sleeping energy expenditure, growth status and gut health and function.
Primary Outcome
Investigators will examine the effects of 12 weeks of Ivacaftor treatment on subject's SEE. Using indirect calorimetry, SEE will be assessed using a computerized metabolic cart Vmax ENCORE at each protocol visit while the child is asleep. SEE will be assessed in the morning if possible and careful note of previous feeding of the child, including the time of day, amount of food, and feeding interval prior to test
Interventions
- DRUG Ivacaftor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-02-06 |
| Est. Completion | 2021-12-30 |
What the finished NCT03783286 record still lists
NCT03783286 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Ivacaftor is the first listed.
NCT03783286 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03783286 about?
NCT03783286 is a clinical study titled "Ivacaftor Treatment in 4 Month to 2 Year Old CF Subjects". The purpose of this research study is to determine the effects of clinically prescribed ivacaftor treatment on 4-24 month old children with CF and gating mutations on sleeping energy expenditure, growth status and gut health and function.
What is the current status of trial NCT03783286?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2019-02-06. Estimated completion is 2021-12-30.
What interventions are being tested in trial NCT03783286?
The interventions under investigation include: Ivacaftor (DRUG).
Who is sponsoring clinical trial NCT03783286?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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