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Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations

Study acronym: MAV-RAPA
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Sep 2024 to Sep 2027v10
  2. 2 versions Re-verified since Aug 23, 2021, no change to tracked fieldsv8-v9
  3. Primary and study completion dates: Sep 2020 to Sep 2024v7
  4. Primary completion date: Jan 2018 to Sep 2020v6 Show 4 more changesShow less
    • Study completion date: Jun 2018 to Sep 2020
    • Start date: Sep 2014 to Sep 12, 2014
    • Secondary endpoints revised (5)
    • Site details revised at 3 of 13 sites
  5. 3 versions Re-verified since Jul 28, 2015, no change to tracked fieldsv3-v5
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2015 to Sep 2014
    • Site details revised at 13 of 13 sites
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 aim of the study is to evaluate the efficacy and safety of sirolimus (oral form), to decrease the volume and symptoms due to superficial arteriovenous malformations (AVM). Sirolimus has properties that reduce the activity of the immune system (immunosuppressant), to fight against the proliferation of cancer cells (anti- tumor) and also reduce the proliferation of blood vessels (anti -vascular). Sirolimus is primarily used in transplant patients to prevent organ transplant rejection. Many animal and laboratory studies were carried out and demonstrate in particular the activity of sirolimus on vessels. It is this anti- vascular effect that could help treat arteriovenous malformations.
Trial Details
NCT Number NCT02042326
Lead Sponsor Centre Hospitalier Universitaire, Amiens
Conditions
(from sponsor)		 Arteriovenous Malformations
Related terms Arteriovenous Malformations
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov