Overview
Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis
Status:
Terminated
Terminated
Trial end date:
2017-06-02
2017-06-02
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
PTC Therapeutics
Criteria
Inclusion Criteria:- Completion of study treatment (placebo or active) in the previous Phase 3,
double-blind study protocol (Protocol PTC124-GD-021-CF)
- Evidence of signed and dated informed consent/assent document(s) indicating that the
participant (and/or the participant's parent/legal guardian) has been informed of all
pertinent aspects of the trial.
Exclusion Criteria:
- Known hypersensitivity to any of the ingredients or excipients of the study drug.
- Ongoing participation in any other therapeutic clinical trial.