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Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)
NCT02139306 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ataluren (PTC124®)
Study Locations (20)
California
- Miller Children's Hospital Long Beach — Long Beach
- Children's Hospital Los Angeles — Los Angeles
- Children's Hospital and Research Center at Oakland — Oakland
- Stanford University-Children's Hospital — Palo Alto
Florida
- Nemours Children's Clinic — Jacksonville
- University of Miami — Miami
- Miami Children's Hospital — Miami
- All Children's Hospital — St. Petersburg
New York
- Beth Israel Medical Center — New York
- New York University Langone Medical Center — New York
- Columbia University Medical Center — New York
Alabama
- University of Alabama at Birmingham — Birmingham
- Pulmonary Associates of Mobile PC — Mobile
New Jersey
- Monmouth Medical Center — Long Branch
- Morristown Medical Center — Morristown
Colorado
- Children's Hospital Colorado — Aurora
Illinois
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago
Indiana
- Indiana University — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02139306
The ClinicalTrials.gov registry entry for NCT02139306 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PTC Therapeutics, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02139306 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02139306 about?
NCT02139306 is a clinical study titled "Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)". This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.
What is the current status of trial NCT02139306?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 279 participants. The study started on 2014-08. Estimated completion is 2016-11.
What conditions does trial NCT02139306 study?
This clinical trial studies the following conditions: Cystic Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02139306?
The interventions under investigation include: Placebo (DRUG), Ataluren (PTC124®) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02139306?
This trial is sponsored by PTC Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02139306 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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