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 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT04120168
Eligibility Criteria:
Inclusion Criteria:
* 3 months -18 years old boys and girls
* Serum transaminase levels (serum ALT and / or AST levels\> 1.52 upper limit of normal (ULN)) for at least 3 months
* The willingness of the patient and / or legal representative to sign the written consent form
Exclusion Criteria:
* Patients less than 3 months
* Patients with a known history of liver disease
* Patients with a known history of muscle disease
* Patients with a known history of rheumatologic disease
* Patients with clinical history or physical examination findings that support the possibility of liver disease (Jaundice, variceal bleeding, hepatomegaly, splenomegaly, ascites)
* ICU patients
* Patients with known congenital anomalies
* Patients with organ failure
* Patients with elevated serum GGT, Total Bliribun or Direct Bilirubin levels
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
18 Years
Study:
NCT04120168
Study Brief:
Protocol Section:
NCT04120168