Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT01811667
Eligibility Criteria:
Inclusion Criteria:
* Patients with complex vascular abnormalities to be threat by a systemic therapy
* Patients must have adequate liver function (LDL-cholesterol, triglycerides,…)
* Patients must have adequate organ function: neutrophils \>1500/mm³, Hb \> 8,0 g et platelets\> 50.000/mm³ (no platelets limits for the Kasabach Merritt syndrome)
* Patients must have adequate renal function(normal creatinin depending on the age), clearance \> 70 ml/min/1.73m² and Urin Protein Creatinine ratio \<0.3 g.
* Karnofsky or Landry \> 50
Exclusion Criteria:
* Dental equipments or prosthesis interfering onto a radiological examen
* Other uncontrolled medical condition (uncontrolled diabetes, hypertension…)
* Concomitant drugs such as inhibitors/inducers of cytochrome P450 3A4 (CYP3A4)
* Immunocompromised patients, including known seropositivity for HIV
* Digestive problems modifying the absorption of Rapamycin (gastric tube feeding accepted)
* Pregnant or nursing (lactating) women
* Prior treatment with phosphatidylinositol 3-kinase (PI3K) and/or mTOR inhibitors
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
70 Years
Study:
NCT01811667
Study Brief:
Protocol Section:
NCT01811667