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:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT07072403
Eligibility Criteria:
Inclusion Criteria:
* -Presenting a complicated vascular anomalies vascular anomalies with the following characteristics:
1. Male and female;
2. Between 1 and 18 years of age;
3. Complicated vascular anomalies vascular anomalies diagnosis was confirmed by local investigators and by consensus of our multidisciplinary vascular anomaly group at the West China Hospital of Sichuan University based on:
Biopsy; Compatible MRI findings; History and clinical features.
Exclusion Criteria:
1. Patients have allergy or contraindication to MEK inhibitor
2. Exposure to chemotherapy, embolization, corticosteroids, propranolol, sclerotherapy or any other investigational agents within 1 weeks before enrolment on study;
3. Patients had a history of a major surgery within 2 weeks before enrollment;
4. Any known evidence of significant local or systemic uncontrolled infection, defined as receiving intravenous antibiotics at the time of enrollment;
5. Impairment of gastrointestinal function or chronic gastrointestinal disease that may significantly alter the absorption of trametinib.
6. Concurrent severe and/or uncontrolled medical diseases that could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe malnutrition, chronic liver or renal disease, active upper gastrointestinal tract ulceration).
7. Patients with inadequate liver function:
Total bilirubin higher than or equal to 1.5 × the upper limit of the normal (ULN) for age and alanine aminotransferase and aspartate aminotransferase higher than or equal to 2.5 × the ULN for age.
8. Patients with inadequate renal function:
0-5 years of age maximum serum creatinine (mg/dL) of 0.8; 6-10 years of age maximum serum creatinine (mg/dL) of 1.0; 11-14 years of age maximum serum creatinine (mg/dL) of 1.2;
9. Adequate bone marrow function:
Absolute neutrophil count lower than 1 × 109/L;
10. History of a malignancy within 5 years;
11. HIV infection or known immunodeficiency;
12. Patients with an inability to participate in or follow-up during the study treatment and assessment plan;
13. Inability to give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT07072403
Study Brief:
Protocol Section:
NCT07072403