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NCT02107859 · ClinicalTrials.gov registry record · Phase 3
Study of Ataluren (PTC124) in Cystic Fibrosis
A Phase 3 study, sponsored by PTC Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
NCT02107859: Clinical Trial Phase 3 study, sponsored by PTC Therapeutics.
NCT02107859 is a Phase 3 study that was terminated before completion, run by PTC Therapeutics. The registered enrollment target is 61 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02107859, a Phase 3 study, was terminated before completion, sponsored by PTC Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the long-term safety and tolerability of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) who completed participation in the double-blind study PTC124-GD-009-CF (NCT00803205), as assessed by adverse events and laboratory abnormalities. The secondary objective of this study includes the assessment of the efficacy of ataluren, as measured by forced expiratory volume in 1 second (FEV1) and pulmonary exacerbation rate, and other safety parameters (for example, 12-lead electrocardiogram \[ECG\] measurements, vital signs).
Primary Outcome
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of an AE was classified as: mild (does not interfere with usual function), moderate (interferes to some extent with usual function), severe (interferes significantly with usual function), life threatening (results in potential threat to life), and fatal AEs. Drug-related AEs: AEs with a possible or probable relationship to study drug. Serious AEs: death, a l
Interventions
- DRUG Ataluren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2014-05-23 |
| Est. Completion | 2017-06-05 |
| Phase | Phase 3 |
Why NCT02107859 stopped before completion
NCT02107859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Ataluren is the first listed.
NCT02107859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02107859 about?
NCT02107859 is a clinical study titled "Study of Ataluren (PTC124) in Cystic Fibrosis". The primary objective of this study is to determine the long-term safety and tolerability of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) who completed participation in the double-blind study PTC124-GD-009-CF (NCT00803205), as assessed by adverse events and laboratory abnor...
What is the current status of trial NCT02107859?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2014-05-23. Estimated completion is 2017-06-05.
What interventions are being tested in trial NCT02107859?
The interventions under investigation include: Ataluren (DRUG).
Who is sponsoring clinical trial NCT02107859?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02107859's enrollment target sits among peer trials
61 1803rd of 2000 higher than 197 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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