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

NCT05508633 | Enrolling By Invitation Phase 2

• 1 other identifier: CZXH2022002.01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Portal Hypertension

Keywords

Portal hypertension; Alverine

Outcome Measures

Primary Outcomes (1)

• Change in portal pressure

  Change in portal pressure from baseline to 2 hours after start of orally administration

  Change in portal pressure from baseline to 2 hours after start of orally administration

Secondary Outcomes (1)

• Treatment response rate

  2 hours

Study Arms (2)

Low dose Alverine

EXPERIMENTAL

Alverine 60mg (1 capsule), orally

Drug: Alverine Citrate

High dose Alverine

EXPERIMENTAL

Alverine 120mg (2 capsules), orally

Drug: Alverine Citrate

Interventions

Alverine Citrate DRUG

Low-dose group: Alverine (60 mg, 1 capsule) High-dose group: Alverine (120 mg, 2 capsules) The drug is orally given with 200 ml warm water after measurement of the baseline portal pressure.

High dose Alverine; Low dose Alverine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Use of non-selective beta-blockers (e.g. carvedilol, propranolol) or statins within 1 month prior to dosing.
• Moderate or massive ascites, overt hepatic encephalopathy, gastrointestinal bleeding and other complications within 1 week.
• Previous splenectomy, cardia periesophageal vascular dissection, transjugular intrahepatic portosystemic shunt (TIPS), liver transplantation, etc.
• 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).
• 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.
• Any uncontrolled active infection (e.g. lung infection, abdominal infection, HIV, etc) 4 weeks prior to enter in the study.
• Patient who are allergy to the experimental drug.
• Patients with abnormal mental symptoms or taking tricyclic antidepressants and similar drugs in the past 4 weeks.
• 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng hospital

Shanghai, Shanghai Municipality, 200001, China

Location

MeSH Terms

Conditions

Hypertension, Portal

Interventions

alverine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Wei-Fen Xie

  Director of department of gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, department of gastroenterology

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 19, 2022
• Study Start: October 28, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

CN (1)