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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT05022693
Eligibility Criteria:
Key Inclusion Criteria:
* Age 21 to 65
* Diagnosis of NASH with compensated cirrhosis by a hepatologist based on Liver Forum criteria.
* Model for End-Stage Liver Disease (MELD) score \< 12.
* Child-Turcotte-Pugh (CTP) score \< 7 (Class A).
* Fibrosis stage F4 by FibroScan.
Key Exclusion Criteria:
* History of hepatic cirrhosis decompensation, OR overt hepatic encephalopathy OR signs of hepatic cirrhosis decompensation.
* Prior transjugular intrahepatic portosystemic (TIPS) shunt procedure.
* known condition other than cirrhosis that may possibly interfere with drug absorption, distribution, metabolism, or excretion.
* Significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT05022693
Study Brief:
Protocol Section:
NCT05022693