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NCT02139306 · ClinicalTrials.gov registry record · Phase 3

Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)

A Phase 3 study of Cystic Fibrosis, sponsored by PTC Therapeutics.

Completed
Registry status
Phase 3
Development phase
279
Enrollment target
20
Study locations

NCT02139306 is a Phase 3 study of Cystic Fibrosis that has completed, run by PTC Therapeutics. The registered enrollment target is 279 participants, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (57% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT02139306, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by PTC Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
279 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Ataluren (PTC124®)

Study Locations (20)

California

  • Miller Children's Hospital Long Beach - Long Beach
  • Children's Hospital Los Angeles - Los Angeles
  • Children's Hospital and Research Center at Oakland - Oakland
  • Stanford University-Children's Hospital - Palo Alto

Florida

  • Nemours Children's Clinic - Jacksonville
  • University of Miami - Miami
  • Miami Children's Hospital - Miami
  • All Children's Hospital - St. Petersburg

New York

  • Beth Israel Medical Center - New York
  • New York University Langone Medical Center - New York
  • Columbia University Medical Center - New York

Alabama

  • University of Alabama at Birmingham - Birmingham
  • Pulmonary Associates of Mobile PC - Mobile

New Jersey

  • Monmouth Medical Center - Long Branch
  • Morristown Medical Center - Morristown

Colorado

  • Children's Hospital Colorado - Aurora

Illinois

  • Ann and Robert H. Lurie Children's Hospital of Chicago - Chicago

Indiana

  • Indiana University - Indianapolis

Trial Details

FieldValue
Enrollment Target 279 participants
Start Date 2014-08
Est. Completion 2016-11
Phase Phase 3

Sponsor

PTC Therapeutics

52 total trials

What the Registry Record Tells You About NCT02139306

The ClinicalTrials.gov registry entry for NCT02139306 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (57% higher). The listed sponsor is PTC Therapeutics, which has 52 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02139306 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT02139306 about?

NCT02139306 is a clinical study titled "Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)". 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.

What is the current status of trial NCT02139306?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 279 participants. The study started on 2014-08. Estimated completion is 2016-11.

What conditions does trial NCT02139306 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT02139306?

The interventions under investigation include: Placebo (DRUG), Ataluren (PTC124®) (DRUG).

Who is sponsoring clinical trial NCT02139306?

This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02139306 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.