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Compound Alverine Citrate Capsules for Cirrhotic Portal Hypertension Treatment

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Study Aim

This study aims to evaluate the safety and response rate of Alverine Citrate Capsules in treating Cirrhotic Portal Hypertension, by observing the reduction in hepatic venous pressure gradient and monitoring any adverse events after 24 weeks of treatment.

What is being tested

Alverine

+ Carvedilol

Drug
Who is being recruted

Digestive System Diseases

+ Liver Diseases

+ Hypertension, Portal

From 18 to 80 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: June 2024
See protocol details

Summary

Principal SponsorShanghai Changzheng Hospital
Study ContactChang-Peng Zhu, M.D.
Last updated: June 24, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2024

Actual date on which the first participant was enrolled.

This clinical trial is exploring the effectiveness and safety of Compound Alverine Citrate Soft Capsules for treating portal hypertension in patients with liver cirrhosis. Portal hypertension is a condition where there is increased blood pressure in the veins of the liver, which can lead to serious complications in people with liver cirrhosis. The study aims to compare the effects of Alverine Citrate with Carvedilol, a commonly used medication for this condition. By investigating these treatments, the study hopes to find more effective ways to manage portal hypertension and reduce the risk of complications such as bleeding from enlarged veins in the stomach and esophagus. Participants in the study are randomly assigned to receive either Alverine Citrate or Carvedilol for 24 weeks. Those in the Alverine group take capsules containing 60 mg of Alverine Citrate and 300 mg of Simethicone, three times daily. Carvedilol, on the other hand, is taken once or twice a day, with the dose adjusted based on the participant's heart rate and blood pressure. The study evaluates how well each treatment reduces blood pressure in the liver, using measurements like the hepatic venous pressure gradient (HVPG). Safety is also closely monitored to track any adverse events. The study also looks at other factors, such as liver function and survival rates, to better understand the potential benefits and any risks associated with the treatments.

NCT06470386
Principal SponsorShanghai Changzheng Hospital
Study ContactChang-Peng Zhu, M.D.
Last updated: June 24, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

178 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesLiver DiseasesHypertension, Portal

Criteria

4 inclusion criteria required to participate
Hepatic venous pressure gradient (HVPG) ≥ 10 mmHg.
Age 18 to 80 years (inclusive), regardless of gender.
Patients with cirrhosis confirmed by clinical, laboratory, imaging examinations, and/or liver biopsy.
Agree to participate and sign the informed consent form.
18 exclusion criteria prevent from participating
Significant renal insufficiency (eGFR (CKD-EPI formula) <20 mL/min/1.73 m²).
Use of vasoactive drugs such as somatostatin and its analogs, vasopressin, terlipressin, dopamine, norepinephrine within 1 week prior to enrollment.
Presence of thrombosis or cavernous transformation in the portal venous system (including portal vein, splenic vein, superior mesenteric vein); patients with a history of portal vein thrombosis can be enrolled if no definite thrombosis is detected in the portal venous system within 2 weeks.
Known allergy to Alverine, Papaverine and their derivatives (e.g., Papaverine Hydrochloride, Drotaverine Hydrochloride) or Carvedilol; contraindications for Carvedilol: NYHA class IV decompensated heart failure requiring intravenous inotropic drugs; asthma, chronic obstructive pulmonary disease (COPD) with bronchospasm; second or third degree atrioventricular block, severe bradycardia (heart rate less than 50 bpm), sick sinus syndrome (including sinoatrial block); cardiogenic shock; severe hypotension (systolic blood pressure less than 85 mmHg).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Compound Alverine Citrate Capsules (Lejiansu; specification: each capsule contains 60 mg of Alverine Citrate and 300 mg of Simethicone; manufactured by the French company UCB Pharma), 180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks.

Group II

Active Comparator
Jinluo (Carvedilol Tablets; specification: 6.25 mg; manufactured by Qilu Pharmaceutical Co., Ltd.), taken orally, starting dose of 6.25 mg once a day, gradually adjusted according to heart rate to 6.25 mg twice a day, 12.5 mg in the morning and 6.25 mg in the evening, 12.5 mg twice a day, or adjusted to the maximum tolerated dose (heart rate greater than 55 beats/min and systolic blood pressure greater than 90 mmHg), taken continuously for 24 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

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