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NOT YET RECRUITING
NCT06696248
PHASE2/PHASE3

Carvedilol and Alverine in Portal Hypertension

Sponsor: Shanghai Changzheng Hospital

View on ClinicalTrials.gov

Summary

Brief summaries of CZXH-PH-ALV-2403 The goal of this clinical trial is to learn if the combination of alverine and carvedilol works to treat portal hypertension in adult patients with liver cirrhosis. It will also learn about the safety of alverine. The main question it aims to answer is: For patients with liver cirrhosis and portal hypertension who have been treated with carvedilol at a dose of up to 15 mg/day or at a lower dose that is the maximum tolerated for at least 3 months, and still have a hepatic venous pressure gradient (HVPG) of 12 mmHg or higher and up to and including 20 mmHg, can the addition of alverine help to reduce portal hypertension? On the basis of maintaining unchanged routine hepatoprotective and symptomatic supportive treatments and the original dose of carvedilol, participants will be administered with compound alverine citrate capsules (Le Jian Su; specification: each capsule contains alverine citrate 60 mg and simeticone 300 mg; manufactured by Laboratoires MAYOLY SPINDLER), at a dosage of 180 mg/day (1 capsule orally, 3 times a day), for a continuous period of 24 weeks.

Official title: The Efficacy of Carvedilol Combined with Compound Alverine Citrate Soft Capsules in the Treatment of Portal Hypertension in Patients with Liver Cirrhosis: a Prospective, Open-label, Multicentre, Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-11-15

Completion Date

2025-09-30

Last Updated

2024-11-20

Healthy Volunteers

No

Interventions

DRUG

Carvedilol and alverine

On the basis of maintaining unchanged routine hepatoprotective and symptomatic supportive treatments and the original dose of carvedilol, participants will be administered with compound alverine citrate capsules (Le Jian Su; specification: each capsule contains alverine citrate 60 mg and simeticone 300 mg; manufactured by Laboratoires MAYOLY SPINDLER), at a dosage of 180 mg/day (1 capsule orally, 3 times a day), for a continuous period of 24 weeks.