The Instant Efficacy and Safety of Alverine in Decreasing Portal Hypertension: an Exploratory Pilot Study

Korábbi kezelés

• Use of non-selective beta-blockers (e.g. carvedilol, propranolol) or statins within 1 month prior to dosing.
• Previous splenectomy, cardia periesophageal vascular dissection, transjugular intrahepatic portosystemic shunt (TIPS), liver transplantation, etc.
• Any uncontrolled active infection (e.g. lung infection, abdominal infection, HIV, etc) 4 weeks prior to enter in the study.
• Patients with abnormal mental symptoms or taking tricyclic antidepressants and similar drugs in the past 4 weeks.

Más betegség

• Moderate or massive ascites, overt hepatic encephalopathy, gastrointestinal bleeding and other complications within 1 week.
• Presence of hepatic vein, portal vein, splenic vein thrombosis or cavernous transformation of the portal vein.
• Poorly controllable hypertension or diabetic patient; severe background disease like chronic respiratory failure, circulatory failure, kidney failure etc.
• Clinically diagnosed or suspected as malignancy, including hepatocellular carcinoma.
• Patient who are allergy to the experimental drug.

Laborértékek

• Coagulopathy, including platelet count < 50× 10\^9/ L, international normalized ratio (INR) of prothrombin time ≥1.5.
• Serum total bilirubin ≥ 5 fold of upper limits of normal; serum sodium level < 125 mmol/ L; white blood cell count < 1× 10\^9/ L.
• Severe chronic renal insufficiency (eGFR (CKD-EPI) < 20 ml/min/1.73 m2).

Egyéb

• Gestation or lactation period women and women who plan to get pregnant during the study period.
• Patients who are participating other trials or have taken part in other in the past 4 weeks.
• Other situation where PI thinks the patient should be excluded.

• Age 18-75 years.
• Confirmed evidence of cirrhosis/ Cirrhosis diagnosed by liver biopsy or by imaging studies showing a nodular liver, splenomegaly and/or collateral.
• Portal pressure greater than equal to (≥)10 mmHg.
• Signed informed consent.