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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 is a Phase 3 study that was terminated before completion, run by PTC Therapeutics. The registered enrollment target is 61 participants.
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).
Interventions
- DRUG Ataluren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2014-05-23 |
| Est. Completion | 2017-06-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02107859
The ClinicalTrials.gov registry entry for NCT02107859 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PTC Therapeutics, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ataluren is the first listed.
NCT02107859 reports 0 study locations.
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.
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