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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT06121492
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 18 and 85 years.
* Patients who have been diagnosed with liver cirrhosis due to any etiology.
* Patients with sarcopenia as determined by a computed tomography scan within the last 3 months. For males, sarcopenia is defined as a Skeletal Muscle Index (SMI) less than 42 cm²/m², and for females, an SMI less than 38 cm²/m²
Exclusion Criteria:
* Patients with hepatocellular carcinoma outside the Milan criteria.
* Patients with Overt Hepatic Encephalopathy or gastrointestinal bleeding within the last 6 months.
* Patients with refractory ascites (ascites that does not respond to treatment).
* Patients in the advanced stage of cirrhosis with Child-Turcotte-Pugh (CTP) score C.
* Patients with acute-on-chronic liver failure (ACLF).
* Patients with uncontrollable decompensated comorbidities, including chronic heart failure classified as NYHA 3-4, patients with kidney disease requiring dialysis, patients with severe obstructive lung disease classified as Gold D, patients with other non-liver cancers requiring chemotherapy, and patients with chronic infections such as tuberculosis.
* Patients who have previously undergone liver or kidney transplantation.
* Patients with Human Immunodeficiency Virus (HIV) infection.
* Pregnant or breastfeeding patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06121492
Study Brief:
Protocol Section:
NCT06121492