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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT03468556
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 20 years
2. Body weight ≥ 54 kg
3. Diagnosis of non-alcoholic steatohepatitis (NASH) as evidenced by imaging or other diagnostic assessments. Subject should have documented liver fat content ≥ 10.0 % as measured by MRI method prior to study drug administration.
4. Alanine aminotransferase (ALT) levels ≥ 2.0x upper limit of normal (ULN) on at least two occasions, seven or more days apart, prior to study drug administration
5. Have adequate organ functions as defined by the following examinations prior to the start of study treatment:
1. Hematology: Hemoglobin ≥ 9 g/dL, a platelet count ≥ 100 x 10\^9/L, and a white blood cell count ≥ 3.0 x 10\^9/L
2. Renal: creatinine clearance ≥ 90 mL/min (by Cockcroft-Gault equation), serum uric acid \< 9.0 mg/dL
6. Able to provide written informed consent, and understand and comply with the requirements of the study
Exclusion Criteria:
1. Decompensated or severe liver disease as evidenced by one or more of the following:
1. Confirmed cirrhosis or suspicion of cirrhosis
2. Liver transplant
3. Liver malignancy
4. Ascites
5. Bilirubin \>2 x ULN, or ALT or AST \> 10 x ULN
6. Acute or chronic hepatitis A, B, C, HIV, or other liver diseases affecting liver function.
Patients with cysts, hemangiomas, or similar abnormalities, are accepted.
2. History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years
3. Subjects who are unable to undergo an MRI scan.
4. Subjects have electronically, magnetically and mechanically activated implanted devices, including but not limited to automatic cardioverter defibrillators, cardiac pacemakers, insulin pumps, metallic splinters in the eye, ferromagnetic haemostatic clips in central nervous systems or vascular vessels.
5. Significant systemic or major illness other than liver disease, including auto-immune disease, coronary artery disease, cerebrovascular disease, malignant neoplasms, pulmonary disease, renal insufficiency, serious psychiatric disease, and/or other serious disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study
6. Documented history of serious allergic reaction to SNP-610 or any structurally related compounds
7. Diabetic patients who have not maintained a stable dose of oral medication for hyperglycemia or have had more than 10 percent change in their insulin dose over the past two months
8. Regular use of agents that are potent against hepatitis or affecting lipid metabolisms, including but not limited to HMGCoA reductase inhibitors (statins), fibrates, silymarin, N-acetylcysteine, or anti-TNF therapies.
Note: refer to Section 6.5 Prohibited agents for details.
9. Pregnant or lactating
10. Female of child-bearing potential who are not committed to take reliable contraception during the participation of the study and at least 4 weeks after the end of the study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03468556
Study Brief:
Protocol Section:
NCT03468556