drugset / Trial / NCT02456103

Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis

NCT02456103

Phase 3 Terminated 246 enrolled PTC Therapeutics
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-08-31
Primary completion
2017-06-02
Completion
2017-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Ataluren Small molecule 10 mg/kg Oral
Subject Ataluren Small molecule 20 mg/kg Oral

Indications