deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT04058366

Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

Sponsor: Vertex Pharmaceuticals Incorporated

Conditions Cystic Fibrosis
Interventions ELX/TEZ/IVA IVA
Updated 17 times since 2019 Last updated: Dec 15, 2023 Started: Dec 5, 2019 Primary completion: Dec 16, 2022 Completion: Dec 16, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04058366, this PHASE3 trial focuses on Cystic Fibrosis and remains completed. Sponsored by Vertex Pharmaceuticals Incorporated, it has been updated 17 times since 2019, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Feb 2020 · 4 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Feb 2022 · 12 months · monthly snapshot~Feb 2022 – ~Sep 2022 · 7 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~Feb 2024 · 12 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

17 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Feb 2024 — Jul 2024 [monthly]

    Completed PHASE3

  5. Feb 2023 — Feb 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

▶ Show 12 earlier versions

  1. Sep 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  2. Feb 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  3. Feb 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE3

  4. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE3

  5. Aug 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: Enrolling By Invitation → Active Not Recruiting

  6. Jul 2020 — Aug 2020 [monthly]

    Enrolling By Invitation PHASE3

  7. May 2020 — Jul 2020 [monthly]

    Enrolling By Invitation PHASE3

  8. Apr 2020 — May 2020 [monthly]

    Enrolling By Invitation PHASE3

  9. Mar 2020 — Apr 2020 [monthly]

    Enrolling By Invitation PHASE3

  10. Feb 2020 — Mar 2020 [monthly]

    Enrolling By Invitation PHASE3

    Status: Not Yet Recruiting → Enrolling By Invitation

  11. Oct 2019 — Feb 2020 [monthly]

    Not Yet Recruiting PHASE3

  12. Sep 2019 — Oct 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Vertex Pharmaceuticals Incorporated
Data source: Vertex Pharmaceuticals Incorporated

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

Study Locations

Amsterdam, Netherlands , Ancona, Italy , Ann Arbor, United States , Austin, United States , Barcelona, Spain , Benite Cedex, France , Berlin, Germany , Bordeaux, France , Boston, United States , Brussels, Belgium and 67 more locations