Hypertension, PortalPhase 2/3NCT06473493
The Safety and Efficacy of Alverine in the Treatment of Cirrhotic Portal Hypertension
A Phase 2/3 study testing Alverine in people with Hypertension, Portal, run by Shanghai Changzheng Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Portal
- What is being tested?
- Alverine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Mar 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Safety and Efficacy of Compound Alverine Citrate Soft Capsules in the Treatment of Portal Hypertension in Patients With Liver Cirrhosis: a Multicentre, Single-arm, Exploratory Trial s: a Multicentre, Single-arm, Exploratory Trial
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
Read more
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
- Hypertension, Portal
- Being tested
- Alverine
- Keywords
- Portal hypertension, Alverine, Pharmacological therapy
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlverineDrug
Also called Compound Alverine Citrate Capsules
180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Alverine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (6)
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
Measured: 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
Measured: 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.
Measured: 24 weeks
12-week response rate
The treatment response rate at 12 weeks
Measured: 12 weeks
Mortality rate
Rates of death and liver disease-related mortality during the treatment period
Measured: 24 weeks
Transplantation rate
Rates of liver transplantation during the treatment period
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PortalStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai East Hospital, Daping Hospital, Army Medical Center of PLA
- Responsible party
- Principal investigator, Wei-Fen Xie, Shanghai Changzheng Hospital
- Investigators
- Wei-Fen Xie, M.D., Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473493
- Sponsor's protocol ID
- CZXH-PH-ALV-2402
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Compound Alverine Citrate Soft Capsules in the Treatment of Portal Hypertension in Patients With Liver Cirrhosis: a Multicentre, Single-arm, Exploratory Trial s: a Multicentre, Single-arm, Exploratory Trial
- ClinicalTrials.gov ID
- NCT06473493
- Acronym / sponsor ID
- CZXH-PH-ALV-2402
- Conditions
- Hypertension, Portal
- Keywords
- Portal hypertension, Alverine, Pharmacological therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Shanghai East Hospital, Daping Hospital, Army Medical Center of PLA
- Study start
- Jun 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alverine Group | Experimental | Drug: AlverineCompound 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlverineAlso: Compound Alverine Citrate Capsules180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks | Drug | Alverine Group |
Primary outcome
Safety assessment: the incidence of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment.
Time frame: 24 weeks
The incidence of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment.
24-week response rate
Time frame: 24 weeks
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.
6 secondary outcomes
HVPG changes: 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
Time frame: 24 weeks
The incidence of decompensation events
Time frame: 24 weeks
12-week response rate
Time frame: 12 weeks
Mortality rate
Time frame: 24 weeks
Transplantation rate
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Fen Xie, M.D. principal investigator
Shanghai Changzheng Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alverine in people with Hypertension, Portal, run by Shanghai Changzheng Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang-Peng Zhu, M.D. (86-13671547663, zhuchangpeng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment: the incidence of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment. (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.