Study of Ataluren (PTC124) in Cystic Fibrosis
Stopped early · Phase 3
Conditions studied: Cystic Fibrosis
In brief
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).
Key facts
- Study ID
- NCT02107859
- Run by
- PTC Therapeutics
- People needed
- 61
- Starts
- 2014-05-23
- Expected to finish
- 2017-06-05
- Last updated by the study team
- 2020-03-25
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama-Birmingham — Birmingham, Alabama, United States
- Miller Children's Hospital Long Beach — Long Beach, California, United States
- Denver Children's Hospital — Aurora, Colorado, United States
- Children's Hospital Chicago — Chicago, Illinois, United States
- Children's Hospital Boston — Boston, Massachusetts, United States
- Beth Israel Medical Center — New York, New York, United States
- Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States
- Hôpital Universitaire des Enfants Reine Fabiola — Brussels, Belgium
- University Hospital Brussels — Brussels, Belgium
- University Hospital Leuven — Leuven, Belgium
- Hôpital Necker - Enfants Malades — Paris, France
- Hôpital des Enfants — Toulouse, France
- Hadassah University Hospital - Mount Scopus — Jerusalem, Israel
- Università La Sapienza — Roma, Italy
- Azienda Ospedaliera di Verona — Verona, Italy
- Hospital Universitario La Paz — Madrid, Spain
- Karolinska University Hospital, Huddinge — Stockholm, Sweden
Full record on ClinicalTrials.gov
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