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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02443818
Eligibility Criteria:
Inclusion Criteria:
* Post-zygotic PIK3CA mutation
* Age: 3-65 years
* Measurable overgrowth, in current progression or with clinical history of overgrowth progression
* Patient clinically stable
* Presence of a disability, social or cosmetic impairment requiring treatment from the patient perspective,
* Written informed consent form signed and dated by the subject or by the patient's legal representative
Exclusion Criteria:
* Pregnancy or lactation
* Women and men of reproductive age without any effective method of contraception (during treatment and up to 12 weeks after sirolimus discontinuation)
* Hypersensitivity to the active substance (sirolimus) or to any of the excipients
* Impossibility to obtain written informed consent form signed by the subject or the patient's legal representative, or vulnerable adults
* Treatment with Sirolimus in the last 4 weeks before the trial
* Personal history of malignancy or current investigations for suspected malignancy
* Active skin infection requiring antibiotics or antiviral treatments
* HIV or hepatitis B or C infection
* Past history of Mycobacterium tuberculosis infection
* Active pneumopathy
* Uncontrolled infection
* Chronic liver disease (ASAT or Alanine amino transférase (ALAT)\> 3 times upper normal limit)
* Stage 3 (or more) chronic renal insufficiency (eGFR\< 60mls/min)
* Neutropenia with neutrophiles \< 1.0 x10\^9/L
* Uncontrolled dyslipidemia
* Inability to attend study visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
65 Years
Study:
NCT02443818
Study Brief:
Protocol Section:
NCT02443818