deltatrials
Completed PHASE4 INTERVENTIONAL 4-arm NCT03924947

A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

A Phase 4 Study to Compare US Marketed Creon Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site and With Drug Product Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Subjects With EPI Due to Cystic Fibrosis

Sponsor: AbbVie

Conditions Cystic Fibrosis
Interventions Pancrelipase
Updated 18 times since 2019 Last updated: Sep 25, 2023 Started: Oct 23, 2019 Primary completion: Jul 11, 2022 Completion: Jul 11, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03924947, this PHASE4 trial focuses on Cystic Fibrosis and remains completed. Sponsored by AbbVie, it has been updated 18 times since 2019, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~May 2019 – ~Nov 2019 · 6 months · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Jun 2020 · 4 months · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Nov 2020 · 4 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~Nov 2021 · 7 months · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Jul 2022 · 4 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Oct 2023 · 13 months · monthly snapshot~Oct 2023 – ~Jul 2024 · 9 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

18 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Oct 2023 — Jul 2024 [monthly]

    Completed PHASE4

  4. Sep 2022 — Oct 2023 [monthly]

    Completed PHASE4

    Status: Active Not Recruiting → Completed

  5. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE4

    Status: Recruiting → Active Not Recruiting

▶ Show 13 earlier versions

  1. Mar 2022 — Jul 2022 [monthly]

    Recruiting PHASE4

  2. Jan 2022 — Mar 2022 [monthly]

    Recruiting PHASE4

  3. Nov 2021 — Jan 2022 [monthly]

    Recruiting PHASE4

  4. Apr 2021 — Nov 2021 [monthly]

    Recruiting PHASE4

  5. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE4

  6. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE4

  7. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE4

  8. Jul 2020 — Nov 2020 [monthly]

    Recruiting PHASE4

  9. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE4

  10. Feb 2020 — Jun 2020 [monthly]

    Recruiting PHASE4

  11. Dec 2019 — Feb 2020 [monthly]

    Recruiting PHASE4

  12. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE4

    Status: Not Yet Recruiting → Recruiting

  13. May 2019 — Nov 2019 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • AbbVie
Data source: AbbVie

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

Study Locations

Cleveland, United States , Columbus, United States , Iowa City, United States , Jacksonville, United States , Los Angeles, United States , Nashville, United States , Northfield, United States , Orlando, United States , Philadelphia, United States , Richmond, United States and 2 more locations