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:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT01553500
Eligibility Criteria:
Inclusion Criteria:
* informed consent by parents or legal tutor
* ALT levels \<10 ULN
* hyperechogenicity at liver ultrasound examination suggestive of fatty liver
* INR \< 1,3
* Albumin \> 3 g/dl
* total bilirubin \< 2,5 mg/dl
* no previous gastrointestinal bleeding
* no previous portosystemic encephalopathy
* normal renal function
* no HIV-HCV-HDV infection
* normal cell blood count
Exclusion Criteria:
* every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
* finding of active liver disease due to other causes
* corticosteroids, immunosuppressive drugs or chemotherapy in the 2 months before of the study
* alcohol consumption
* use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
* finding of actual or previous level of alpha-fetoprotein \> 50 ng/ml
* hepatocellular carcinoma
* diabetes mellitus type I
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
16 Years
Study:
NCT01553500
Study Brief:
Protocol Section:
NCT01553500