Trials / Terminated
TerminatedNCT02456103
Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis
Phase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Cystic Fibrosis
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 246 (actual)
- Sponsor
- PTC Therapeutics · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The primary objective of this Phase 3 extension study will be to obtain long-term safety data to augment the overall safety database. The secondary objectives will be to augment the efficacy data collected in the double-blind study (PTC124-GD-021-CF; NCT02139306).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ataluren | Ataluren will be provided as a vanilla-flavored powder to be mixed with water or milk. |
Timeline
- Start date
- 2015-08-31
- Primary completion
- 2017-06-02
- Completion
- 2017-06-02
- First posted
- 2015-05-28
- Last updated
- 2020-04-27
- Results posted
- 2020-04-15
Locations
70 sites across 16 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02456103. Inclusion in this directory is not an endorsement.