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NCT02456103 · ClinicalTrials.gov registry record · Phase 3
Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis
A Phase 3 study, sponsored by PTC Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 246
- Enrollment target
NCT02456103: Clinical Trial Phase 3 study, sponsored by PTC Therapeutics.
NCT02456103 is a Phase 3 study that was terminated before completion, run by PTC Therapeutics. The registered enrollment target is 246 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02456103, a Phase 3 study, was terminated before completion, sponsored by PTC Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 246 participants
- Enrollment target
Study Summary
This is an open-label extension study for participants who completed a Phase 3, placebo-controlled study of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.
Primary Outcome
TEAE: any untoward medical occurrence or undesirable event that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. Serious adverse event (SAE): an adverse event (AE) resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying) or persistent or significant disability/incapacity. Except for cystic
Interventions
- DRUG Ataluren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2015-08-31 |
| Est. Completion | 2017-06-02 |
| Phase | Phase 3 |
Why NCT02456103 stopped before completion
NCT02456103 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Ataluren is the first listed.
NCT02456103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02456103 about?
NCT02456103 is a clinical study titled "Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis". This is an open-label extension study for participants who completed a Phase 3, placebo-controlled study of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.
What is the current status of trial NCT02456103?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 246 participants. The study started on 2015-08-31. Estimated completion is 2017-06-02.
What interventions are being tested in trial NCT02456103?
The interventions under investigation include: Ataluren (DRUG).
Who is sponsoring clinical trial NCT02456103?
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 NCT02456103's enrollment target sits among peer trials
246 1267th of 2000 higher than 734 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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