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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT05508633
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years.
2. Confirmed evidence of cirrhosis/ Cirrhosis diagnosed by liver biopsy or by imaging studies showing a nodular liver, splenomegaly and/or collateral.
3. Portal pressure greater than equal to (≥)10 mmHg.
4. Signed informed consent.
Exclusion Criteria:
1. Use of non-selective beta-blockers (e.g. carvedilol, propranolol) or statins within 1 month prior to dosing.
2. Moderate or massive ascites, overt hepatic encephalopathy, gastrointestinal bleeding and other complications within 1 week.
3. Previous splenectomy, cardia periesophageal vascular dissection, transjugular intrahepatic portosystemic shunt (TIPS), liver transplantation, etc.
4. Coagulopathy, including platelet count \< 50× 10\^9/ L, international normalized ratio (INR) of prothrombin time ≥1.5.
5. Serum total bilirubin ≥ 5 fold of upper limits of normal; serum sodium level \< 125 mmol/ L; white blood cell count \< 1× 10\^9/ L.
6. Severe chronic renal insufficiency (eGFR (CKD-EPI) \< 20 ml/min/1.73 m2).
7. Presence of hepatic vein, portal vein, splenic vein thrombosis or cavernous transformation of the portal vein.
8. Poorly controllable hypertension or diabetic patient; severe background disease like chronic respiratory failure, circulatory failure, kidney failure etc.
9. Clinically diagnosed or suspected as malignancy, including hepatocellular carcinoma.
10. Any uncontrolled active infection (e.g. lung infection, abdominal infection, HIV, etc) 4 weeks prior to enter in the study.
11. Patient who are allergy to the experimental drug.
12. Patients with abnormal mental symptoms or taking tricyclic antidepressants and similar drugs in the past 4 weeks.
13. Gestation or lactation period women and women who plan to get pregnant during the study period.
14. Patients who are participating other trials or have taken part in other in the past 4 weeks.
15. Other situation where PI thinks the patient should be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05508633
Study Brief:
Protocol Section:
NCT05508633