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Carvedilol and Alverine in Portal Hypertension

ConditionHypertension, Portal
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Changzheng Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 18 to 80 years old (inclusive), no gender restrictions;

Patients with liver cirrhosis diagnosed by clinical, laboratory, imaging examinations, and/or liver biopsy;

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, with HVPG≥12 mmHg and ≤20 mmHg;

Agree to participate and sign the informed consent form.

Disqualifiers

Those who have taken alverine, papaverine, or their derivatives (such as papaverine hydrochloride preparations, trimebutine maleate, etc.) within 4 weeks before enrollment;

Those who have undergone transjugular intrahepatic portosystemic shunt (TIPS) or other interventional treatments affecting portal pressure (including splenic embolization, splenic microwave treatment, etc.) or liver transplantation;

Those who have had overt hepatic encephalopathy, esophageal and gastric variceal bleeding within 2 weeks before enrollment; those who have undergone endoscopic treatment for esophageal and gastric varices within 1 week before enrollment or are planned for endoscopic treatment;

Those who have used somatostatin and its analogs, vasopressin, terlipressin, dopamine, norepinephrine, and other vasoactive drugs within 1 week before enrollment;

Trial design

Design model

Single group

Treatments tested in this trial

  • Carvedilol and alverine

    Drug

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Carvedilol + Alverine GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The 24-week response rate

The response rate to treatment, defined as the percentage of patients with a decrease in HVPG of ≥10% from baseline or a decrease to below 12 mmHg after 24 weeks of treatment.

Time frame
24 weeks

Secondary outcomes

1

Degree of decrease in HVPG compared to baseline HVPG after 24 weeks of treatment.

Time frame
24 weeks
2

Incidence of cirrhosis decompensation events during treatment.

Incidence of cirrhosis decompensation events (including esophageal and gastric variceal bleeding, new-onset ascites/progression of ascites, spontaneous bacterial peritonitis, overt hepatic encephalopathy, acute kidney injury/hepatorenal syndrome, primary liver cancer, etc.) during treatment.

Time frame
24 weeks
3

The 12-week response rate

The response rate to treatment, defined as the percentage of patients with a decrease in HVPG of ≥10% from baseline or a decrease to below 12 mmHg after 12 weeks of treatment.

Time frame
12 weeks
4

Degree of decrease in HVPG compared to baseline HVPG after 12 weeks of treatment.

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Changzheng Hospital

Lead sponsor

Shanghai East Hospital

Collaborator

Army Medical Center of PLA

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: