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IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)

Study acronym: ABATE
StatusRecruiting
PhasePhase 1
SponsorChris Goss
Started
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Record History

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  1. Primary and study completion dates: Jun 30, 2025 to Mar 31, 2027
    • Site contacts updated at 1 of 10 sites
    v16
  2. Site contacts updated at 1 of 10 sitesv15
  3. Primary completion date: Sep 30, 2024 to Jun 30, 2025
    • Eligibility criteria expanded, about 414 words
    • Study description expanded, about 98 words
    • Site details revised at 1 of 10 sites
    v14
  4. Primary completion date: Sep 30, 2023 to Sep 30, 2024
    • Study sites: 9 to 10
    • Eligibility criteria expanded, about 13 words
    v13
  5. Study completion date: Sep 30, 2024 to Jun 30, 2025
    • Eligibility criteria expanded, about 38 words
    • Site details revised at 2 of 9 sites
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 10 to 9v11
  2. Site details revised at 1 of 10 sitesv10
  3. Site details revised at 1 of 10 sitesv9
  4. Study sites: 2 to 10
    • Eligibility criteria shortened, about 2 words
    v8
  5. Primary completion date: Dec 31, 2022 to Sep 30, 2023
    • Study completion date: Apr 30, 2023 to Sep 30, 2024
    • Start date changed from estimate of May 31, 2021 to Jun 17, 2021
    v7
  6. Re-verified, no change to tracked fieldsv6
  7. Start date: Feb 1, 2021 to May 31, 2021v5
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 1, 2020 to Feb 1, 2021
    • Site details revised at 2 of 2 sites
    v4
  9. Re-verified, no change to tracked fieldsv3
  10. Study title shortened, about 3 wordsv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM. Funding Source - FDA Office of Orphan Products Development (OOPD)
Trial Details
NCT Number NCT04294043
Lead Sponsor Chris Goss
Collaborators: Cystic Fibrosis Foundation
Conditions
(from sponsor)		 Nontuberculous Mycobacterium Infection
Related terms Cystic Fibrosis, Mycobacterium avium-intracellulare Infection, Mycobacterium Infections, Nontuberculous
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov