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Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care

StatusRecruiting
PhasePhase 3
Started
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Record status
This record was last updated February 24, 2023 (before its estimated April 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Oct 2018 to Apr 1, 2025
    • Start date: Nov 2015 to Jan 25, 2016
    • Study completion date: Oct 2025 to Apr 1, 2030
    v5
  2. Study sites: 1 to 3v4
  3. Re-verified, no change to tracked fieldsv3
  4. Secondary endpoints: 6 to 5v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of rapamycin (mTor) pathway plays a role on the development and the venous/lymphatic vascular organisations. The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.
Trial Details
NCT Number NCT02638389
Lead Sponsor Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions
(from sponsor)		 Vascular Malformations
Related terms Vascular Malformations
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov