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 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT06473493
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 80 years (inclusive), regardless of gender.
* Patients diagnosed with cirrhosis through clinical evaluation, laboratory tests, imaging studies, and/or liver biopsy.
* Hepatic venous pressure gradient (HVPG) ≥ 12 mmHg.
* Willingness to participate and sign the informed consent form.
Exclusion Criteria:
* Use of non-selective β-blockers (e.g., carvedilol, propranolol) or alverine, papaverine, and its derivatives (e.g., papaverine hydrochloride, drotaverine hydrochloride) within 4 weeks prior to enrollment.
* Previous transjugular intrahepatic portosystemic shunt (TIPS) or other interventional treatments affecting portal pressure (including splenic embolization, microwave treatment of the spleen).
* Previous liver transplantation.
* Occurrence of overt hepatic encephalopathy or esophageal/gastric variceal bleeding within 2 weeks prior to enrollment; endoscopic treatment of esophageal/gastric varices within 1 week prior to enrollment or planned endoscopic treatment.
* Use of somatostatin and its analogs, vasopressin, terlipressin, dopamine, norepinephrine, and other vasoactive drugs within 1 week prior to enrollment.
* History of alcoholism within 12 weeks prior to enrollment and inability to stop drinking during the study (equivalent ethanol intake ≥ 30 g/day for males, ≥ 20 g/day for females).
* Serum total bilirubin level ≥ 3×ULN (for autoimmune liver disease patients, ≥ 5×ULN), serum sodium level \< 125 mmol/L, white blood cell count \< 1×10\^9/L, platelet count \< 50×10\^9/L, INR \> 1.8, or serum creatinine ≥ 1.2×ULN.
* Presence of thrombosis in the portal venous system (including the portal vein, splenic vein, superior mesenteric vein, etc.) or cavernous transformation of the portal vein; previous portal venous system thrombosis if no definite thrombosis detected in the portal venous system within 2 weeks.
* HBV DNA or HCV RNA above the lower limit of detection; patients undergoing active antiviral treatment for hepatitis C; antiviral treatment for hepatitis B \< 24 weeks.
* Uncontrollable active infections (e.g., pulmonary infection, abdominal infection, HIV) within 2 weeks prior to enrollment.
* Uncontrolled hypertension, diabetes, or other severe heart/lung diseases.
* Diagnosis or suspicion of malignant tumors, including liver cancer.
* Known allergy to alverine or papaverine and its derivatives (e.g., papaverine hydrochloride, drotaverine hydrochloride) or simethicone.
* Presence of psychiatric symptoms.
* Pregnant or breastfeeding women, or women who may be pregnant.
* Participation in other drug trials within 4 weeks prior to enrollment.
* Any other reasons deemed by the researchers as unsuitable for participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06473493
Study Brief:
Protocol Section:
NCT06473493