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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT04669158
Eligibility Criteria:
Inclusion Criteria:
* 1\) Male or non-pregnant/ non-lactating women ≥ 18 years of age
* 2\) Diagnosis of NASH: NAFLD activity score (NAS) of 4 or greater with a score of 1 for each of the following (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2):
* Steatosis
* Lobular inflammation
* Hepatocyte ballooning 3) Fibrosis (Ishak fibrosis score ≥1 on liver biopsy) within 6 months of enrollment with MELD\<10, or based on MRE
Exclusion Criteria:
* Presence of any other form of liver disease, including viral hepatitis, autoimmune hepatitis, alcoholic liver disease, genetic causes of chronic liver disease):
* Subjects with other etiologies of chronic liver disease, such as chronic hepatitis B and C; autoimmune hepatitis; and inherited liver disease.
* ALT\>300 U/l
* Total serum bilirubin ≥ to 1.3 mg/dL (Gilbert's Syndrome patients excepted)
* International Normalized Ratio (INR) ≥ 1.3
* MELD\>10
* Serum creatinine \>2.0mg/dl
* Known alcohol abuse or alcohol use disorder:
* \>20 g/day for women
* \>30 g/day for men
* Active substance abuse
* Any medical condition that prevents MRE, MR-PDFF
* Platelet count ≤100//mm3
* Decompensated cirrhosis
* Hemoglobin \<11 g/dl in females or \<12 g/dl in males
* Presence/history of HCC
* History of liver transplantation
* History of bariatric surgery
* History of inflammatory bowel disease
* History of cardiovascular disease, long QT syndrome.
* Subjects who have participated in investigational drug trials and took any investigational drugs within 60 days prior to the first dose of Idebenone. History of receiving other investigations drug within 30 days prior to enrollment
* Any concerns regarding compliance by enrolling physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04669158
Study Brief:
Protocol Section:
NCT04669158