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Weekly Sirolimus Therapy

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Feb 2026 to Dec 2027 Completion date: Jun 2026 to Dec 2027v9 Show 1 more changeShow less
    • Completion date: Jun 2026 to Dec 2027
  2. Primary completion date: Feb 2025 to Feb 2026 Completion date: Jun 2025 to Jun 2026v8 Show 1 more changeShow less
    • Completion date: Jun 2025 to Jun 2026
  3. Primary completion date: Feb 2024 to Feb 2025 Completion date: Feb 2024 to Jun 2025 · Site contact updatedv7 Show 2 more changesShow less
    • Completion date: Feb 2024 to Jun 2025
    • Site contact updated
  4. Primary and study completion dates: Feb 2023 to Feb 2024v6
  5. Site contact updatedv5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary and study completion dates: May 2022 to Feb 2023 Start date: May 18, 2021 to Jan 18, 2022v4 Show 1 more changeShow less
    • Start date: May 18, 2021 to Jan 18, 2022
  2. Enrollment target: 25 to 24v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of May 2021 to May 18, 2021v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2021 to May 18, 2021
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.
Trial Details
NCT Number NCT04861064
Lead Sponsor Medical University of South Carolina
Conditions Venous Malformation, Lymphatic Malformation
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov