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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this exploratory study was to investigate the instant efficacy and safety of alverine oral administration in decreasing portal hypertension.

Condition of disease: Cirrhotic portal hypertension

Intervention/treatment:

Drug: Alverine 60 mg (1 capsule), orally Drug: Alverine 120 mg (2 capsules), orally

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Changzheng Hospital
• Treatments: Alverine; Mebeverine

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.