[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569592":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":19,"responsibleParty":30,"collaborators":33,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":19,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":19,"studyType":52,"phases":53,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":19,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":19},{"fullName":5,"class":6},"Shanghai Changzheng Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Carvedilol + Alverine Group","EXPERIMENTAL","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\u002Fday (1 capsule orally, 3 times a day), for a continuous period of 24 weeks.",[13],"Drug: Carvedilol and alverine",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Carvedilol and alverine",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Wei-Fen Xie, M.D.","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Chang-Peng Zhu, M.D.","CONTACT","86-13671547663","zhuchangpeng@126.com",{"type":23,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Wei-Fen Xie","Director, Department of Gastroenterology, Changzheng Hospital",[34,36],{"name":35,"class":6},"Shanghai East Hospital",{"name":37,"class":38},"Army Medical Center of PLA","OTHER_GOV","100569592","phase-2-carvedilol-and-alverine-in-portal-hypertension-100569592",false,"NCT06696248","Carvedilol and Alverine in Portal Hypertension","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","Inclusion Criteria:\n\n* Ages 18 to 80 years old (inclusive), no gender restrictions;\n* Patients with liver cirrhosis diagnosed by clinical, laboratory, imaging examinations, and\u002For liver biopsy;\n* Treated with carvedilol at a dose of up to 15 mg\u002Fday or at a lower dose that is the maximum tolerated for at least 3 months, with HVPG≥12 mmHg and ≤20 mmHg;\n* Agree to participate and sign the informed consent form.\n\nExclusion Criteria:\n\n* Those who have taken alverine, papaverine, or their derivatives (such as papaverine hydrochloride preparations, trimebutine maleate, etc.) within 4 weeks before enrollment;\n* 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;\n* 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;\n* Those who have used somatostatin and its analogs, vasopressin, terlipressin, dopamine, norepinephrine, and other vasoactive drugs within 1 week before enrollment;\n* Those with a history of heavy alcohol consumption within 12 weeks before enrollment and cannot abstain from alcohol during the study period (equivalent ethanol intake of ≥30 g\u002Fday for males and ≥20 g\u002Fday for females);\n* Serum total bilirubin levels ≥3×ULN (for patients with autoimmune liver disease, serum total bilirubin levels ≥5×ULN), or serum sodium levels \\\u003C125 mmol\u002FL, or white blood cell count \\\u003C1×10\\^9\u002FL, or platelet count \\\u003C30×10\\^9\u002FL, or International Normalized Ratio (INR) \\>1.8; or serum creatinine ≥1.2×ULN;\n* Presence of thrombosis in the portal venous system (including portal vein, splenic vein, superior mesenteric vein, etc.) and cavernous transformation of the portal vein; those with a history of portal venous system thrombosis who have no definite thrombosis detected in the portal venous system within 2 weeks before enrollment may be included;\n* HBV DNA or HCV RNA \\> the lower limit of detection; patients with active hepatitis C receiving antiviral treatment; those who have received anti-HBV treatment for less than 24 weeks;\n* Those with uncontrollable current infections (pulmonary infections, abdominal infections, HIV, etc.) within 4 weeks before enrollment;\n* Those with poorly controlled hypertension, diabetes, or other severe heart, lung diseases;\n* Those diagnosed or suspected to have malignant tumors, including liver cancer;\n* Known allergies to alverine, papaverine, or their derivatives (such as papaverine hydrochloride preparations, trimebutine maleate, etc.), or simethicone, or carvedilol; patients with contraindications to carvedilol: New York Heart Association Class IV decompensated heart failure requiring intravenous inotropic agents; asthma, chronic obstructive pulmonary disease (COPD) with bronchospasm; second- or third-degree atrioventricular block, severe bradycardia (heart rate less than 50 beats per minute), sick sinus syndrome (including sinoatrial block); cardiogenic shock; severe hypotension (systolic blood pressure less than 85 mmHg);\n* Those with glaucoma;\n* Those with mental abnormalities;\n* Pregnant or breastfeeding women, or women who do not rule out the possibility of pregnancy;\n* Those who have participated in other drug trials within 4 weeks before enrollment;\n* Other reasons the investigator deems unsuitable for participation.","ALL","18 Years","80 Years",{"count":50,"type":51},30,"ESTIMATED","INTERVENTIONAL",[54,55],"PHASE2","PHASE3","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.\n\nThe main question it aims to answer is:\n\nFor patients with liver cirrhosis and portal hypertension who have been treated with carvedilol at a dose of up to 15 mg\u002Fday 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\u002Fday (1 capsule orally, 3 times a day), for a continuous period of 24 weeks.",[58],"Hypertension, Portal",[60,61,62],"Cirrhotic portal hypertension","Alverine","Pharmacological therapy","NOT_YET_RECRUITING","2024-11-17",{"date":66,"type":67},"2024-11-20","ACTUAL",{"date":69,"type":51},"2024-11-15",{"date":71,"type":51},"2025-09-30",{"name":5,"class":6}]