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Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation

Study acronym: NINBOST2018
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Aug 2025 to Dec 2026v10
  2. Re-verified, no change to tracked fieldsv9
  3. Primary and study completion dates: Aug 2024 to Aug 2025
    • Study sites: 2 to 3
    v8
  4. Re-verified, no change to tracked fieldsv7
  5. Primary and study completion dates: Feb 2022 to Aug 2024v6
Show 4 earlier versionsHide 4 earlier versions
  1. Enrollment target: 40 to 20
    • Study sites: 8 to 2
    v5
  2. Primary and study completion dates: Feb 2021 to Feb 2022v4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2019 to Mar 20, 2019
    • Secondary endpoints revised (14)
    • Site details revised at 8 of 8 sites
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study investigates the safety and tolerability of Nintedanib in patients with bronchiolitis obliterans syndrome (BOS) following allogeneic hematopoietic cell transplantation. All study patients with BOS will be treated with the study drug Nintedanib (300 mg/day) as an add-on therapy to their basic immunosuppressive treatment over a 12-months treatment period.
Trial Details
NCT Number NCT03805477
Lead Sponsor University Hospital, Basel, Switzerland
Conditions
(from sponsor)		 Bronchiolitis Obliterans Syndrome (BOS), Bronchiolitis Obliterans (BO)
Related terms Bronchiolitis Obliterans, Bronchiolitis Obliterans Syndrome
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov