CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 279 enrolled
Drug / intervention
Ataluren (PTC124®) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02139306
NCT02139306Phase 3Completed
CompareCT.gov

A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients With Nonsense Mutation Cystic Fibrosis

PTC Therapeutics·interventional·Posted May 15, 2014·Updated May 14, 2020

In Brief

A Phase 3 clinical trial evaluating Ataluren (PTC124®) and Placebo for Cystic Fibrosis. Completed, enrolled 279 participants across 88 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Spain, United Kingdom, United States
CollaboratorsCystic Fibrosis Foundation, ECFS-Clinical Trial Network (ECFS-CTN)

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 15, 2014
Enrollment StartAug 1, 2014
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.1 years ago

Interventions

Ataluren (PTC124®)drug

Oral Ataluren TID

Placebodrug

Oral Placebo TID