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Combined Immunosuppression for Pediatric Crohn's Disease

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Oct 31, 2025 to Oct 31, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v10
  2. 3 versions Re-verified since Sep 20, 2023, no change to tracked fieldsv7-v9
  3. Trial status: Not Yet Recruiting to Recruitingv6 Show 6 more changesShow less
    • Enrollment target: 80 to 128
    • Primary completion date: Aug 1, 2024 to Oct 31, 2025
    • Start date changed from estimate of Jun 15, 2022 to Oct 10, 2022
    • Study sites: 0 to 1
    • Study completion date: Jul 1, 2025 to Dec 31, 2025
    • Eligibility criteria expanded, about 10 words
  4. Enrollment target: 40 to 80
    • Start date: Jun 1, 2022 to Jun 15, 2022
    • Eligibility criteria expanded, about 18 words
    v5
  5. Start date: Apr 1, 2022 to Jun 1, 2022
    • Eligibility criteria revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Dec 1, 2021 to Apr 1, 2022v3
  2. Start date: Oct 1, 2021 to Dec 1, 2021
    • Secondary endpoint revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.
Trial Details
NCT Number NCT05043870
Lead Sponsor Children's Hospital of Fudan University
Conditions
(from sponsor)		 Crohn Disease, Infliximab, Immunosuppression, Children, Only
Related terms Crohn Disease
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov