deltatrials
Completed OBSERVATIONAL NCT04138589

Effect of Lumacaftor/Ivacaftor in Children With Cystic Fibrosis Homozygote for F508del on Small Airway Function (ROOTS)

Real World Data of the Effect of Lumacaftor/Ivacaftor Therapy in Children With Cystic Fibrosis Homozygote for F508del on Small Airway Function

Sponsor: Marien Hospital Wesel

Updated 7 times since 2019 Last updated: Nov 28, 2023 Started: Nov 1, 2017 Primary completion: Jul 19, 2022 Completion: Jul 19, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04138589, this observational or N/A phase trial focuses on Cystic Fibrosis in Children and remains completed. Sponsored by Marien Hospital Wesel, it has been updated 7 times since 2017, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Nov 2019 – ~Dec 2020 · 13 months · monthly snapshotRecruiting~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshotRecruiting~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotRecruiting~Dec 2022 – ~Dec 2023 · 12 months · monthly snapshotUnknown Status~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed

  2. Jul 2024 — Sep 2024 [monthly]

    Completed

  3. Dec 2023 — Jul 2024 [monthly]

    Completed

    Status: Unknown StatusCompleted

  4. Dec 2022 — Dec 2023 [monthly]

    Unknown Status

    Status: RecruitingUnknown Status

  5. Jan 2021 — Dec 2022 [monthly]

    Recruiting

Show 2 earlier versions
  1. Dec 2020 — Jan 2021 [monthly]

    Recruiting

  2. Nov 2019 — Dec 2020 [monthly]

    Recruiting

    First recorded

Nov 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Marien Hospital Wesel
  • University Medical Center Groningen
  • Vertex Pharmaceuticals Incorporated
Data source: University Medical Center Groningen

For direct contact, visit the study record on ClinicalTrials.gov .