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NCT02544451 · ClinicalTrials.gov registry record · Phase 3

Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor

A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
246
Enrollment target

NCT02544451 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 246 participants.

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The verdict

NCT02544451, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
246 participants
Enrollment target

Study Summary

Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.

Interventions

  • DRUG LUM/IVA

Trial Details

FieldValue
Enrollment Target 246 participants
Start Date 2015-08
Est. Completion 2020-04
Phase Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

What the Registry Record Tells You About NCT02544451

The ClinicalTrials.gov registry entry for NCT02544451 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which LUM/IVA is the first listed.

NCT02544451 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02544451 about?

NCT02544451 is a clinical study titled "Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor". Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evalu...

What is the current status of trial NCT02544451?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 246 participants. The study started on 2015-08. Estimated completion is 2020-04.

What interventions are being tested in trial NCT02544451?

The interventions under investigation include: LUM/IVA (DRUG).

Who is sponsoring clinical trial NCT02544451?

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

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.