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NCT03125395 · ClinicalTrials.gov registry record · Phase 3

A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
57
Enrollment target

NCT03125395 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 57 participants.

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The verdict

NCT03125395, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
57 participants
Enrollment target

Study Summary

A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for F508del.

Interventions

  • DRUG LUM/IVA

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2017-05-12
Est. Completion 2019-07-17
Phase Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

What the Registry Record Tells You About NCT03125395

The ClinicalTrials.gov registry entry for NCT03125395 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 57 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.

NCT03125395 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03125395 about?

NCT03125395 is a clinical study titled "A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation". A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for F508del.

What is the current status of trial NCT03125395?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2017-05-12. Estimated completion is 2019-07-17.

What interventions are being tested in trial NCT03125395?

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

Who is sponsoring clinical trial NCT03125395?

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.