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Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

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

Record History

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  1. Primary completion date changed from estimate of Nov 30, 2025 to Aug 31, 2026 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Nov 30, 2026 to Aug 31, 2027
    • Eligibility criteria expanded, about 8 words
    • Site details revised
    • Publications: details revised at 2 of 2 entries
  2. Primary completion date: Nov 16, 2024 to Nov 30, 2025v8 Show 4 more changesShow less
    • Enrollment target: 56 to 70
    • Study completion date: Nov 16, 2024 to Nov 30, 2026
    • Collaborator revised
    • Publications: 1 to 2
  3. Primary and study completion dates: May 16, 2024 to Nov 16, 2024
    • Collaborators expanded, about 5 words
    v7
  4. Primary endpoint revisedv6 Show 5 more changesShow less
    • Primary and study completion dates: Jun 30, 2024 to May 16, 2024
    • Interventions: Placebo to match Tofacitinib (Drug), Tofacitinib 5 mg (Drug) to Placebo to match Tofacitinib (Drug), Tofacitinib 10 MG [Xeljanz] (Drug)
    • Secondary endpoint revised
    • Site contact updated
    • Study title expanded, about 1 word
  5. Primary and study completion dates: Jun 30, 2023 to Jun 30, 2024v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary and study completion dates: Dec 1, 2021 to Jun 30, 2023v4
  2. Phase: Phase 1 to Phase 2v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date changed from estimate of Dec 1, 2018 to Sep 3, 2019
    • Interventions: Placebo to match tofacitinib (Drug), Tofacitinib 5 mg (Drug) to Placebo to match Tofacitinib (Drug), Tofacitinib 5 mg (Drug)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
We intend, with this study, to prove that blocking the molecular mechanisms whose blockade prevents VIDD in animals, will indeed prevent the development of VIDD in humans as well. We believe that this evidence will serve as the required basis for proceeding with large, ICU-based clinical trial(s) of a drug to prevent VIDD.
Trial Details
NCT Number NCT03681275
Lead Sponsor Stanford University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Diaphragm Injury
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov