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Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Study sites: 7 to 6
    • Study completion date: Mar 2026 to Oct 2026
    v37
  2. Minor Primary completion date changed from estimate of May 2025 to Aug 29, 2025
    • Study completion date: May 2025 to Mar 2026
    v36
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 9 to 7
    • Primary completion date: Dec 2024 to May 2025
    • Study completion date: Apr 2025 to May 2025
    v35
  4. Minor Re-verified, no change to tracked fieldsv34
  5. Minor Primary completion date: Sep 2024 to Dec 2024
    • Study completion date: Dec 2024 to Apr 2025
    v33
Show 31 earlier versionsHide 31 earlier versions
  1. Minor Site contacts updated at 2 of 9 sitesv32
  2. Minor Study sites: 8 to 9v31
  3. Minor Primary completion date: Mar 2024 to Sep 2024
    • Study completion date: Oct 2024 to Dec 2024
    v30
  4. Minor Collaborators: 6 to 7v29
  5. Minor Primary completion date: Sep 2023 to Mar 2024
    • Study completion date: Mar 2024 to Oct 2024
    v28
  6. Minor Study sites: 7 to 8
    • Primary completion date: Mar 2023 to Sep 2023
    • Study completion date: Sep 2023 to Mar 2024
    v27
  7. Minor Site contacts updated at 1 of 7 sitesv26
  8. Minor Study sites: 6 to 7
    • Collaborators: 5 to 6
    v25
  9. Minor Re-verified, no change to tracked fieldsv24
  10. Notable Primary completion date: Aug 2022 to Mar 2023
    • Study completion date: Feb 2023 to Sep 2023
    v23
  11. Minor Study completion date: Aug 2022 to Feb 2023v22
  12. Minor Site details revised at 1 of 6 sites
    • Collaborators: 6 to 5
    v21
  13. Minor Site details revised at 4 of 6 sitesv20
  14. Notable Primary completion date: Feb 2021 to Aug 2022
    • Study completion date: Aug 2021 to Aug 2022
    v19
  15. Minor Secondary endpoints revised (13)v18
  16. Minor Re-verified, no change to tracked fieldsv17
  17. Minor Study sites: 7 to 6v16
  18. Minor Collaborators: 4 to 6v15
  19. Minor Site details revised at 1 of 7 sitesv14
  20. Minor Study sites: 4 to 7v13
  21. Minor 2 versions Re-verified since Jan 30, 2019, no change to tracked fieldsv11-v12
  22. Minor Primary completion date: Dec 2021 to Feb 2021
    • Study completion date: Sep 2022 to Aug 2021
    • Site contacts updated at 1 of 4 sites
    v10
  23. Minor Primary completion date: Oct 2021 to Dec 2021
    • Study completion date: Jan 2022 to Sep 2022
    • Eligibility criteria revised
    v9
  24. Notable Primary completion date: Jul 2020 to Oct 2021
    • Study completion date: Jul 2020 to Jan 2022
    v8
  25. Minor Site details revised at 2 of 4 sitesv7
  26. Minor Eligibility criteria revisedv6
  27. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2017 to Apr 11, 2017
    • Site details revised at 4 of 4 sites
    • Collaborators: 5 to 4
    v5
  28. Minor Start date: Apr 2017 to May 2017
    • Secondary endpoints revised (13)
    v4
  29. Minor Site contacts updated at 1 of 4 sitesv3
  30. Minor Start date: Mar 2017 to Apr 2017v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to evaluate the clinical effectiveness and safety of clofazimine when used to treat Mycobacteria avium complex (MAC) lung disease. Funding Source - FDA OOPD
Trial Details
NCT Number NCT02968212
Lead Sponsor Oregon Health and Science University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), National Jewish Health, The University of Texas Health Science Center at Tyler, National Institute of Allergy and Infectious Diseases (NIAID), University of Chicago, Temple University, University of South Florida
Conditions
(from sponsor)
Mycobacterium Avium Complex
Related terms Mycobacterium avium-intracellulare Infection
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov