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NCT01784419 · ClinicalTrials.gov registry record · NA
Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT01784419 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants.
The verdict
NCT01784419, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a study of the short-term effects of ivacaftor on sweat chloride concentration and lung function in cystic fibrosis (CF) patients who fall outside current FDA approval. This new, first of its kind drug is approved for use only in CF patients with the G551D mutation in whom it safely confers considerable benefits. However, it is highly likely that CF patients with many other mutations can benefit similarly from this drug, some of whom can be identified by phenotype or genotype. We will enroll up to 30 CF subjects with clinical presentations in which there is one or more signs of residual CF channel function. The signs of residual function include: normal digestion, concentration of chloride in sweat between 55 and 85, or milder than expected CF disease in a CF patient with severe gene mutations. The primary outcome measure will be the difference in sweat chloride concentration measured in subjects on placebo and on ivacaftor. Secondary outcome measured will be lung function.
Interventions
- DRUG Placebo
- DRUG ivacaftor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-10 |
| Est. Completion | 2015-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01784419
The ClinicalTrials.gov registry entry for NCT01784419 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01784419 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01784419 about?
NCT01784419 is a clinical study titled "Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients". This is a study of the short-term effects of ivacaftor on sweat chloride concentration and lung function in cystic fibrosis (CF) patients who fall outside current FDA approval. This new, first of its kind drug is approved for use only in CF patients with the G551D mutation in whom it safely confers ...
What is the current status of trial NCT01784419?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2013-10. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01784419?
The interventions under investigation include: Placebo (DRUG), ivacaftor (DRUG).
Who is sponsoring clinical trial NCT01784419?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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