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NCT02823470 · ClinicalTrials.gov registry record · Phase 4

A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation

A Phase 4 study, sponsored by Vertex Pharmaceuticals Incorporated.

Terminated
Registry status
Phase 4
Development phase
24
Enrollment target

NCT02823470: Clinical Trial Phase 4 study, sponsored by Vertex Pharmaceuticals Incorporated.

NCT02823470 is a Phase 4 study that was terminated before completion, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02823470, a Phase 4 study, was terminated before completion, sponsored by Vertex Pharmaceuticals Incorporated.

TERMINATED
Registry status
Phase 4
Development phase
24 participants
Enrollment target

Study Summary

The study will evaluate the impact of smart adherence technology for monitoring on lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with Cystic Fibrosis (CF) who are homozygous for the F508del Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) mutation.

Primary Outcome

Percentage adherence was reported in terms of median and full range due to small sample size.

Interventions

  • DRUG LUM/IVA
  • DEVICE activated smart device
  • DEVICE de-activated smart device

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2016-06
Est. Completion 2017-08
Phase Phase 4
Vertex Pharmaceuticals Incorporated

191 total trials

Why NCT02823470 stopped before completion

NCT02823470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 3 interventions - of which LUM/IVA is the first listed.

NCT02823470 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02823470 about?

NCT02823470 is a clinical study titled "A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation". The study will evaluate the impact of smart adherence technology for monitoring on lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with Cystic Fibrosis (CF) who are homozygous for the F508del Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) mutation.

What is the current status of trial NCT02823470?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2016-06. Estimated completion is 2017-08.

What interventions are being tested in trial NCT02823470?

The interventions under investigation include: LUM/IVA (DRUG), activated smart device (DEVICE), de-activated smart device (DEVICE).

Who is sponsoring clinical trial NCT02823470?

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

How this trial's enrollment target compares

Where NCT02823470's enrollment target sits among peer trials

24 1699th of 2000 higher than 276 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT02823470, the US trial registry maintained by the National Library of Medicine. NCT02823470 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.