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NCT04183790 · ClinicalTrials.gov registry record · Phase 3

Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA TC Combination Therapy in Participants With Cystic Fibrosis Who Are 6 Years of Age and Older

A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
64
Enrollment target

NCT04183790 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 64 participants.

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The verdict

NCT04183790, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
64 participants
Enrollment target

Study Summary

The study evaluates the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in participants with cystic fibrosis (CF).

Interventions

  • DRUG IVA
  • DRUG ELX/TEZ/IVA

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2020-02-17
Est. Completion 2024-02-24
Phase Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

What the Registry Record Tells You About NCT04183790

The ClinicalTrials.gov registry entry for NCT04183790 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 64 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 2 interventions - of which IVA is the first listed.

NCT04183790 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04183790 about?

NCT04183790 is a clinical study titled "Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA TC Combination Therapy in Participants With Cystic Fibrosis Who Are 6 Years of Age and Older". The study evaluates the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in participants with cystic fibrosis (CF).

What is the current status of trial NCT04183790?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 64 participants. The study started on 2020-02-17. Estimated completion is 2024-02-24.

What interventions are being tested in trial NCT04183790?

The interventions under investigation include: IVA (DRUG), ELX/TEZ/IVA (DRUG).

Who is sponsoring clinical trial NCT04183790?

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.