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Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis

NCT02456103 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2020-04-27

Study results available
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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.

Conditions

Interventions

DRUG

Ataluren

Ataluren will be provided as a vanilla-flavored powder to be mixed with water or milk.

Sponsors & Collaborators

Principal Investigators

  • Joseph McIntosh, MD · PTC Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02456103 on ClinicalTrials.gov