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A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 17, 2026 (before its estimated October 10, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Eligibility criteria expanded, about 7 words Secondary endpoints: details revised at 2 of 3 entries Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Re-verified, no change to tracked fieldsv14
  3. Primary and study completion moved earlier from Nov 25, 2026 to Oct 10, 2026v13
  4. Re-verified, no change to tracked fieldsv12
  5. Primary and study completion dates: Dec 31, 2026 to Nov 25, 2026v11
Show 9 earlier versionsHide 9 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 10 to confirmed 4 · Site details revised at 4 of 4 sitesv10 Show 2 more changesShow less
    • Enrollment target: estimated 10 to confirmed 4
    • Site details revised at 4 of 4 sites
  2. Primary completion date: Feb 20, 2026 to Dec 31, 2026 Study sites: 3 to 4 · Completion date: Feb 21, 2026 to Dec 31, 2026v9 Show 2 more changesShow less
    • Study sites: 3 to 4
    • Completion date: Feb 21, 2026 to Dec 31, 2026
  3. Eligibility criteria shortened, about 8 wordsv8 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion date: Sep 30, 2024 to Feb 20, 2026 Completion date: Jul 19, 2025 to Feb 21, 2026v7 Show 1 more changeShow less
    • Completion date: Jul 19, 2025 to Feb 21, 2026
  5. Eligibility criteria shortened, about 45 words Site details revised at 1 of 3 sitesv6 Show 1 more changeShow less
    • Site details revised at 1 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Apr 23, 2023 to May 1, 2023v5 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Apr 23, 2023 to May 1, 2023
  7. Start date: Sep 30, 2022 to Apr 23, 2023 Completion date: Sep 30, 2024 to Jul 19, 2025v4 Show 1 more changeShow less
    • Completion date: Sep 30, 2024 to Jul 19, 2025
  8. Eligibility criteria shortened, about 93 words Secondary endpoints: 2 to 3 · Study description expanded, about 9 words · Study title expanded, about 2 wordsv3 Show 3 more changesShow less
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 9 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  9. Start date: May 31, 2022 to Sep 30, 2022 Primary and study completion dates: Apr 30, 2024 to Sep 30, 2024v2 Show 1 more changeShow less
    • Primary and study completion dates: Apr 30, 2024 to Sep 30, 2024
  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.
Novartis
555 trials monitored
See 31 trials at risk
The purpose of this prospective study is to assess the safety and efficacy of everolimus in Taiwanese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC) . Only patients who fulfil the local reimbursement criteria of everolimus for TSC-AML will be included in this study.
Trial Details
NCT Number NCT05252585
Lead Sponsor Novartis Pharmaceuticals
Conditions Renal Angiomyolipoma
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov