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NCT02725567 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation

A Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
57
Enrollment target
20
Study locations

NCT02725567: Completed Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.

NCT02725567 is a Phase 3 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 57 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02725567, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

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

Study Summary

The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of ivacaftor and metabolites in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an ivacaftor-responsive CF transmembrane conductance regulator (CFTR) gene mutation.

Conditions Studied

Interventions

  • DRUG IVA

Study Locations (20)

Other

  • - South Brisbane
  • - Westmead
  • - Toronto
  • - Dublin
  • - Edinburgh
  • - Leicester

Alabama

  • - Birmingham

California

  • - Palo Alto

Georgia

  • - Atlanta

Illinois

  • - Chicago

Indiana

  • - Indianapolis

Maryland

  • - Baltimore

Massachusetts

  • - Boston

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2016-06-02
Est. Completion 2022-06-28
Phase Phase 3
Vertex Pharmaceuticals Incorporated

191 total trials

What the finished NCT02725567 record still lists

NCT02725567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (68% lower).

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

NCT02725567 names 20 study sites across 15 states, led by Other, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT02725567 about?

NCT02725567 is a clinical study titled "A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation". The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of ivacaftor and metabolites in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an ivacaftor-responsive CF transmembrane conductance regulator (CFTR) gene mutation.

What is the current status of trial NCT02725567?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2016-06-02. Estimated completion is 2022-06-28.

What conditions does trial NCT02725567 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT02725567?

The interventions under investigation include: IVA (DRUG).

Who is sponsoring clinical trial NCT02725567?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02725567 being conducted?

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

Similar trials for Cystic Fibrosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02725567's enrollment target sits among peer trials

57 86th of 169 higher than 84 of 169 other Cystic Fibrosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02725567, the US trial registry maintained by the National Library of Medicine. NCT02725567 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.