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| Name | Class |
|---|---|
| Shanghai East Hospital | OTHER |
| Daping Hospital, Army Medical Center of PLA | OTHER |
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Study Overall Design: This trial is a prospective, multi-center, single-arm, exploratory clinical study. Subjects who meet the inclusion criteria and do not meet the exclusion criteria will receive Compound Alverine Citrate Capsules (Lejiansu; specification: each capsule contains 60 mg of Alverine Citrate and 300 mg of Simethicone; produced by Laboratoires Mayoly Spindler, France) after signing the informed consent form. The dosage is 180 mg/day (1 capsule orally three times a day) for a treatment period of 24 weeks. Apart from the baseline period, efficacy will be evaluated at the end of the 24-week treatment period. Safety assessments will be conducted throughout the trial. The safety evaluation will be performed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by the National Cancer Institute.
Study Population: Patients with cirrhotic portal hypertension
Intervention: Compound Alverine Citrate Capsules (Lejiansu; 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.
Study Objectives: To evaluate the safety and efficacy of Compound Alverine Citrate Capsules in treating portal hypertension in patients with cirrhosis.
Study Endpoints Primary Endpoints
Secondary Endpoints
Exploratory Endpoints
Sample Size Calculation: This trial is a single-arm, exploratory clinical study, and plans to enroll 30 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alverine Group | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alverine | Drug | 180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment: the incidence of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment. | The incidence of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment. | 24 weeks |
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HVPG changes: the absolute value change in HVPG from baseline after 24 weeks of treatment | The absolute value change in HVPG from baseline after 24 weeks of treatment | 24 weeks |
| HVPG changes: the percentage change in HVPG from baseline after 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac function changes | Changes in cardiac function (LVEF) from baseline after 24 weeks of treatment | 24 weeks |
| Liver stiffness changes | Changes in liver stiffness from baseline after 24 weeks of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang-Peng Zhu, M.D. | Contact | 86-13671547663 | zhuchangpeng@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei-Fen Xie, M.D. | Shanghai Changzheng Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C010846 | alverine |
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The percentage change in HVPG from baseline after 24 weeks of treatment |
| 24 weeks |
| The incidence of decompensation events | Incidence of cirrhosis decompensation events during treatment, including esophageal/gastric variceal bleeding and re-bleeding, new or worsening ascites, spontaneous bacterial peritonitis, overt hepatic encephalopathy, and acute kidney injury/hepatorenal syndrome. | 24 weeks |
| 12-week response rate | The treatment response rate at 12 weeks | 12 weeks |
| Mortality rate | Rates of death and liver disease-related mortality during the treatment period | 24 weeks |
| Transplantation rate | Rates of liver transplantation during the treatment period | 24 weeks |
| 24 weeks |
| Spleen stiffness changes | Changes in spleen stiffness from baseline after 24 weeks of treatment | 24 weeks |
| Esophageal varices changes | Size of esophageal varices after 24 weeks of treatment | 24 weeks |