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NCT02564354 · ClinicalTrials.gov registry record · Phase 1
Exploratory Study to Evaluate QR-010 in Subjects With Cystic Fibrosis ΔF508 CFTR Mutation
A Phase 1 study, sponsored by ProQR Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02564354: Completed Phase 1 study, sponsored by ProQR Therapeutics.
NCT02564354 is a Phase 1 study that has completed, run by ProQR Therapeutics. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02564354, a Phase 1 study, has completed, sponsored by ProQR Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Exploratory proof of concept study to determine whether intranasal administration of QR-010 in subjects with cystic fibrosis, homozygous or compound heterozygous for the ΔF508 mutation, can increase the function of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR).
Primary Outcome
The primary endpoint was the within-subject change from baseline in total chloride transport as measured by NPD, after the Chloride-free+isoproterenol solution (Cl-free+iso), and was based on the average measurements of both nostrils. To provide baseline stability, baseline was defined as the average of the two most recent pre-dose values, where each pre-dose value was the average of two nostrils. A negative change from baseline of Cl-free+iso shows an improvement.
Interventions
- DRUG QR-010
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
What the finished NCT02564354 record still lists
NCT02564354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which QR-010 is the first listed.
NCT02564354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02564354 about?
NCT02564354 is a clinical study titled "Exploratory Study to Evaluate QR-010 in Subjects With Cystic Fibrosis ΔF508 CFTR Mutation". Exploratory proof of concept study to determine whether intranasal administration of QR-010 in subjects with cystic fibrosis, homozygous or compound heterozygous for the ΔF508 mutation, can increase the function of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR).
What is the current status of trial NCT02564354?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2015-09. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02564354?
The interventions under investigation include: QR-010 (DRUG).
Who is sponsoring clinical trial NCT02564354?
This trial is sponsored by ProQR Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02564354's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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