Status unknownNCT06473493Updated Jun 25, 2024

The Safety and Efficacy of Alverine in the Treatment of Cirrhotic Portal Hypertension

A Phase 2/3 interventional study of Alverine in Hypertension, Portal, sponsored by Shanghai Changzheng Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by Shanghai Changzheng Hospital · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 30
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study summary

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

Safety Assessment: Incidence of adverse events, serious adverse events, and adverse events leading to discontinuation of treatment (evaluated according to CTCAE version 5.0).
Efficacy Assessment: The response rate at 24 weeks of treatment, defined as a reduction in HVPG by ≥ 10% from baseline or a reduction to below 12 mmHg.

Secondary Endpoints

HVPG Changes: The absolute value and percentage change in HVPG from baseline after 24 weeks of treatment.
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.
12-Week Response Rate: The treatment response rate at 12 weeks.
Mortality and Transplantation: Rates of death, liver transplantation, and liver disease-related mortality during the treatment period.

Exploratory Endpoints

Cardiac Function: Changes in cardiac function from baseline after 24 weeks of treatment.
Liver and Spleen Stiffness: Changes in liver and spleen stiffness from baseline after 24 weeks of treatment.
Esophageal Varices: Status of esophageal varices after 24 weeks of treatment.

Sample Size Calculation: This trial is a single-arm, exploratory clinical study, and plans to enroll 30 subjects.

Conditions studied

Hypertension, Portal

Browse trials for

Hypertension, Portal 345

Keywords

Portal hypertension
Alverine
Pharmacological therapy

In context

Hypertension, Portal

345 studies on the registry are indexed under Hypertension, Portal; 110 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 210 interventional studies indexed under Hypertension, Portal.

Browse Hypertension, Portal studies →

Lead sponsor

Shanghai Changzheng Hospital is the lead sponsor of 128 studies on the registry; 60 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age between 18 and 80 years (inclusive), regardless of gender.
Patients diagnosed with cirrhosis through clinical evaluation, laboratory tests, imaging studies, and/or liver biopsy.
Hepatic venous pressure gradient (HVPG) ≥ 12 mmHg.
Willingness to participate and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

Use of non-selective β-blockers (e.g., carvedilol, propranolol) or alverine, papaverine, and its derivatives (e.g., papaverine hydrochloride, drotaverine hydrochloride) within 4 weeks prior to enrollment.
Previous transjugular intrahepatic portosystemic shunt (TIPS) or other interventional treatments affecting portal pressure (including splenic embolization, microwave treatment of the spleen).
Previous liver transplantation.
Occurrence of overt hepatic encephalopathy or esophageal/gastric variceal bleeding within 2 weeks prior to enrollment; endoscopic treatment of esophageal/gastric varices within 1 week prior to enrollment or planned endoscopic treatment.
Use of somatostatin and its analogs, vasopressin, terlipressin, dopamine, norepinephrine, and other vasoactive drugs within 1 week prior to enrollment.
History of alcoholism within 12 weeks prior to enrollment and inability to stop drinking during the study (equivalent ethanol intake ≥ 30 g/day for males, ≥ 20 g/day for females).
Serum total bilirubin level ≥ 3×ULN (for autoimmune liver disease patients, ≥ 5×ULN), serum sodium level \< 125 mmol/L, white blood cell count \< 1×10\^9/L, platelet count \< 50×10\^9/L, INR > 1.8, or serum creatinine ≥ 1.2×ULN.
Presence of thrombosis in the portal venous system (including the portal vein, splenic vein, superior mesenteric vein, etc.) or cavernous transformation of the portal vein; previous portal venous system thrombosis if no definite thrombosis detected in the portal venous system within 2 weeks.
HBV DNA or HCV RNA above the lower limit of detection; patients undergoing active antiviral treatment for hepatitis C; antiviral treatment for hepatitis B \< 24 weeks.
Uncontrollable active infections (e.g., pulmonary infection, abdominal infection, HIV) within 2 weeks prior to enrollment.
Uncontrolled hypertension, diabetes, or other severe heart/lung diseases.
Diagnosis or suspicion of malignant tumors, including liver cancer.
Known allergy to alverine or papaverine and its derivatives (e.g., papaverine hydrochloride, drotaverine hydrochloride) or simethicone.
Presence of psychiatric symptoms.
Pregnant or breastfeeding women, or women who may be pregnant.
Participation in other drug trials within 4 weeks prior to enrollment.
Any other reasons deemed by the researchers as unsuitable for participation.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants (estimated)

Study arms

Experimental
Alverine Group
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
Drug: Alverine

Interventions

DrugAlverine
180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks
Also known as: Compound Alverine Citrate Capsules

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 24 weeks

Secondary outcomes

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
Time frame: 24 weeks
HVPG changes: the percentage change in HVPG from baseline after 24 weeks of treatment
The percentage change in HVPG from baseline after 24 weeks of treatment
Time frame: 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.
Time frame: 24 weeks
12-week response rate
The treatment response rate at 12 weeks
Time frame: 12 weeks
Mortality rate
Rates of death and liver disease-related mortality during the treatment period
Time frame: 24 weeks
Transplantation rate
Rates of liver transplantation during the treatment period
Time frame: 24 weeks

Other outcomes

Cardiac function changes
Changes in cardiac function (LVEF) from baseline after 24 weeks of treatment
Time frame: 24 weeks
Liver stiffness changes
Changes in liver stiffness from baseline after 24 weeks of treatment
Time frame: 24 weeks
Spleen stiffness changes
Changes in spleen stiffness from baseline after 24 weeks of treatment
Time frame: 24 weeks
Esophageal varices changes
Size of esophageal varices after 24 weeks of treatment
Time frame: 24 weeks

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2024; primary completion for Mar 2025, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 13, 2024
First posted: Jun 25, 2024
StartEst.: Jun 2024
Primary completionEst.: Mar 2025
CompletionEst.: Mar 2025
Last update: Jun 25, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06473493
Lead sponsor: Shanghai Changzheng Hospital
Collaborators: Shanghai East Hospital, Daping Hospital, Army Medical Center of PLA
Responsible party: Wei-Fen Xie (Director, Department of Gastroenterology, Changzheng Hospital, Shanghai Changzheng Hospital) — Principal investigator
First posted: Jun 25, 2024
Start date: Jun 2024 (estimated)
Primary completion: Mar 2025 (estimated)
Completion: Mar 2025 (estimated)
Last update: Jun 25, 2024

Study contacts

Chang-Peng Zhu, M.D.

Contact

zhuchangpeng@126.com

86-13671547663

Wei-Fen Xie, M.D.

principal investigator · Shanghai Changzheng Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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