[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypertension-portal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypertension-portal":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,70,86,110,138,159],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100628473","vagus-nerve-guided-laparoscopic-splenectomy-and-azygoportal-disconnection-100628473",false,"NCT07462091","Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection","VNLSD","Inclusion Criteria:\n\n1. A clinical, radiological or histologic diagnosis of cirrhosis of any etiology\n2. Splenomegaly with secondary hypersplenism\n3. Bleeding portal hypertension\n4. No evidence of portal vein system thrombosis by ultrasound evaluation and angio-CT\n5. Informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Delayed gastric emptying\n2. Diarrhea\n3. Hepatocellular carcinoma or any other malignancy,\n4. Hypercoagulable state other than the liver disease related\n5. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.\n6. Child - Pugh C\n7. Recent peptic ulcer disease\n8. History of Hemorrhagic stroke\n9. Pregnancy.\n10. Uncontrolled Hypertension\n11. Human immunodeficiency virus (HIV) infection","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study aimed to evaluate the effectiveness and safety of vagus nerve-guided laparoscopic splenectomy and azygoportal disconnection, and to assess its impact on postoperative digestive complications and quality of life.",[26,27,28],"Cirrhosis","Hypersplenism","Hypertension, Portal",[30,31,26,32,33],"Laparoscopy","Vagus nerve","Azygoportal disconnection","Splenectomy","RECRUITING","2026-03-26",{"date":37,"type":38},"2026-04-01","ACTUAL",{"date":40,"type":38},"2026-03-25",{"date":42,"type":20},"2027-03-31",{"name":44,"class":45},"Northern Jiangsu People's Hospital","OTHER",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100628431","efficacy-of-apixaban-in-the-treatment-of-portal-vein-thrombosis-occurring-more-than-one-year-after-ls-100628431","NCT07461545","Efficacy of Apixaban in the Treatment of Portal Vein Thrombosis Occurring More Than One Year After LS","Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy","Inclusion Criteria:\n\n1. A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.\n2. Splenomegaly with secondary hypersplenism.\n3. No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery.\n4. Underwent laparoscopic splenectomy at our center.\n5. Orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily or a 100 mg aspirin tablet (Bayer, Leverkusen, Germany) once daily for 6 months from POD 3.\n6. subcutaneous injections of low molecular weight heparin sodium (CSBio, Hebei, China) were administered for 5 days from POD 3\n7. Oral dipyridamole (Henan Furen, Henan, China) at a dosage of 25 mg, administered three times daily for 3 months from POD 3.\n8. Had no imaging evidence (Doppler ultrasound or CT) of portal vein thrombosis during postoperative months 6 to 12.\n9. Developed portal vein thrombosis after 12 months post-surgery.\n10. Provided informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Hepatocellular carcinoma or any other malignancy.\n2. Hypercoagulable state other than the liver disease related.\n3. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.\n4. Portal hypertension bleeding .\n5. Child - Pugh C\n6. Recent peptic ulcer disease\n7. History of Hemorrhagic stroke\n8. Pregnancy.\n9. Uncontrolled Hypertension\n10. Human immunodeficiency virus (HIV) infection",{"count":55,"type":20},20,[23],"The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis Occurring more than one year after laparoscopic splenectomy.",[26,33,59,28],"Portal Vein Thrombosis",[26,59,61,62,33,30],"Portal Hypertension","Apixaban",{"date":64,"type":38},"2026-03-31",{"date":37,"type":20},{"date":67,"type":20},"2027-09-30",{"name":44,"class":45},1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":84,"leadSponsor":85,"locationsCount":69},"100628430","efficacy-of-apixaban-in-treating-portal-vein-thrombosis-occurring-more-than-one-year-after-lsd-100628430","NCT07461532","Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After LSD","Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy and Azygoportal Disconnection","Inclusion Criteria:\n\n1. A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.\n2. Portal hypertension bleeding .\n3. Splenomegaly with secondary hypersplenism.\n4. No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery.\n5. Underwent laparoscopic splenectomy at our center.\n6. Orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily or a 100 mg aspirin tablet (Bayer, Leverkusen, Germany) once daily for 6 months from POD 3.\n7. subcutaneous injections of low molecular weight heparin sodium (CSBio, Hebei, China) were administered for 5 days from POD 3\n8. Oral dipyridamole (Henan Furen, Henan, China) at a dosage of 25 mg, administered three times daily for 3 months from POD 3.\n9. Had no imaging evidence (Doppler ultrasound or CT) of portal vein thrombosis during postoperative months 6 to 12.\n10. Developed portal vein thrombosis after 12 months post-surgery.\n11. Provided informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Hepatocellular carcinoma or any other malignancy.\n2. Hypercoagulable state other than the liver disease related.\n3. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.\n4. Child - Pugh C\n5. Recent peptic ulcer disease\n6. History of Hemorrhagic stroke\n7. Pregnancy.\n8. Uncontrolled Hypertension\n9. Human immunodeficiency virus (HIV) infection",{"count":55,"type":20},[23],"The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis Occurring more than one year after laparoscopic splenectomy and azygoportal disconnection.",[26,33,59,28],[26,59,61,62,33,30,27,32],{"date":64,"type":38},{"date":37,"type":20},{"date":67,"type":20},{"name":44,"class":45},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":69},"100417803","phase-2-shape-of-portal-hypertension-in-children-100417803","NCT04720456","SHAPE of Portal Hypertension in Children","Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children","Inclusion Criteria:\n\n* Patients with a diagnosis of chronic liver disease without portal hypertension.\n* Patients with a diagnosis of chronic liver disease with portal hypertension.\n\nExclusion Criteria:\n\n* Subjects who are pregnant.\n* Patients with known or suspected hypersensitivity to egg phosphatidyl serine or with a history of anaphylactic allergy to eggs or egg products.\n* Subjects with allergy to egg products or other components of the ultrasound contrast agents will be excluded.\n* History of allergic reaction to Lumason®, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)\n* History of allergic reaction to Sonazoid\n* Patients with biliary atresia with asplenia or polysplenia.\n* Patients with prior liver transplant.\n* Patients with cystic fibrosis.\n* Patients with chronic lung disease.\n* Patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein.\n* Adults not competent\u002Fimpaired.\n* Patients with significant heart disease or severe congenital heart disease","6 Years","21 Years",{"count":96,"type":20},120,[98],"PHASE2","Early diagnosis of portal hypertension is difficult as symptoms rarely manifest until the later stages of liver disease. Both cirrhotic and non-cirrhotic portal hypertension can result in life-threatening complications, the most frequent of which is bleeding from esophageal varices. In children, variceal bleeds are associated with mortality rates of 1-3 %, while life-threatening complications have been reported in up to 20 % of children with cirrhosis. Despite the high incidence of portal hypertension in children with liver disease, a noninvasive modality to monitor disease progression and risk of complications is currently lacking. Hence, this trial will investigate the safety and efficacy of subharmonic aided pressure estimation (SHAPE) as a noninvasive ultrasound technique for diagnosing portal hypertension in children.",[28],"2025-02-07",{"date":103,"type":38},"2025-02-11",{"date":105,"type":38},"2021-11-03",{"date":107,"type":20},"2025-08",{"name":109,"class":45},"Thomas Jefferson University",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":4},"100569592","phase-2-carvedilol-and-alverine-in-portal-hypertension-100569592","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.","80 Years",{"count":119,"type":20},30,[98,121],"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.",[28],[125,126,127],"Cirrhotic portal hypertension","Alverine","Pharmacological therapy","NOT_YET_RECRUITING","2024-11-17",{"date":131,"type":38},"2024-11-20",{"date":133,"type":20},"2024-11-15",{"date":135,"type":20},"2025-09-30",{"name":137,"class":45},"Shanghai Changzheng Hospital",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":4},"100552469","phase-2-the-safety-and-efficacy-of-alverine-in-the-treatment-of-cirrhotic-portal-hypertension-100552469","NCT06473493","The Safety and Efficacy of Alverine in the Treatment of Cirrhotic Portal Hypertension","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","Inclusion Criteria:\n\n* Age between 18 and 80 years (inclusive), regardless of gender.\n* Patients diagnosed with cirrhosis through clinical evaluation, laboratory tests, imaging studies, and\u002For liver biopsy.\n* Hepatic venous pressure gradient (HVPG) ≥ 12 mmHg.\n* Willingness to participate and sign the informed consent form.\n\nExclusion Criteria:\n\n* 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.\n* Previous transjugular intrahepatic portosystemic shunt (TIPS) or other interventional treatments affecting portal pressure (including splenic embolization, microwave treatment of the spleen).\n* Previous liver transplantation.\n* Occurrence of overt hepatic encephalopathy or esophageal\u002Fgastric variceal bleeding within 2 weeks prior to enrollment; endoscopic treatment of esophageal\u002Fgastric varices within 1 week prior to enrollment or planned endoscopic treatment.\n* Use of somatostatin and its analogs, vasopressin, terlipressin, dopamine, norepinephrine, and other vasoactive drugs within 1 week prior to enrollment.\n* History of alcoholism within 12 weeks prior to enrollment and inability to stop drinking during the study (equivalent ethanol intake ≥ 30 g\u002Fday for males, ≥ 20 g\u002Fday for females).\n* Serum total bilirubin level ≥ 3×ULN (for autoimmune liver disease patients, ≥ 5×ULN), serum sodium level \\\u003C 125 mmol\u002FL, white blood cell count \\\u003C 1×10\\^9\u002FL, platelet count \\\u003C 50×10\\^9\u002FL, INR \\> 1.8, or serum creatinine ≥ 1.2×ULN.\n* 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.\n* HBV DNA or HCV RNA above the lower limit of detection; patients undergoing active antiviral treatment for hepatitis C; antiviral treatment for hepatitis B \\\u003C 24 weeks.\n* Uncontrollable active infections (e.g., pulmonary infection, abdominal infection, HIV) within 2 weeks prior to enrollment.\n* Uncontrolled hypertension, diabetes, or other severe heart\u002Flung diseases.\n* Diagnosis or suspicion of malignant tumors, including liver cancer.\n* Known allergy to alverine or papaverine and its derivatives (e.g., papaverine hydrochloride, drotaverine hydrochloride) or simethicone.\n* Presence of psychiatric symptoms.\n* Pregnant or breastfeeding women, or women who may be pregnant.\n* Participation in other drug trials within 4 weeks prior to enrollment.\n* Any other reasons deemed by the researchers as unsuitable for participation.",{"count":119,"type":20},[98,121],"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\u002Fday (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.\n\nStudy Population: Patients with cirrhotic portal hypertension\n\nIntervention: 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\u002Fday (1 capsule orally, 3 times a day), taken continuously for 24 weeks.\n\nStudy Objectives: To evaluate the safety and efficacy of Compound Alverine Citrate Capsules in treating portal hypertension in patients with cirrhosis.\n\nStudy Endpoints Primary Endpoints\n\n1. Safety Assessment: Incidence of adverse events, serious adverse events, and adverse events leading to discontinuation of treatment (evaluated according to CTCAE version 5.0).\n2. 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.\n\nSecondary Endpoints\n\n1. HVPG Changes: The absolute value and percentage change in HVPG from baseline after 24 weeks of treatment.\n2. Decompensation Events: Incidence of cirrhosis decompensation events during treatment, including esophageal\u002Fgastric variceal bleeding and re-bleeding, new or worsening ascites, spontaneous bacterial peritonitis, overt hepatic encephalopathy, and acute kidney injury\u002Fhepatorenal syndrome.\n3. 12-Week Response Rate: The treatment response rate at 12 weeks.\n4. Mortality and Transplantation: Rates of death, liver transplantation, and liver disease-related mortality during the treatment period.\n\nExploratory Endpoints\n\n1. Cardiac Function: Changes in cardiac function from baseline after 24 weeks of treatment.\n2. Liver and Spleen Stiffness: Changes in liver and spleen stiffness from baseline after 24 weeks of treatment.\n3. Esophageal Varices: Status of esophageal varices after 24 weeks of treatment.\n\nSample Size Calculation: This trial is a single-arm, exploratory clinical study, and plans to enroll 30 subjects.",[28],[150,126,127],"Portal hypertension","2024-06-18",{"date":153,"type":38},"2024-06-25",{"date":155,"type":20},"2024-06",{"date":157,"type":20},"2025-03",{"name":137,"class":45},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100552230","phase-2-the-efficacy-and-safety-of-alverine-in-the-treatment-of-portal-hypertension-in-patients-with-liver-cirrhosis-100552230","NCT06470386","The Efficacy and Safety of Alverine in the Treatment of Portal Hypertension in Patients With Liver Cirrhosis","The Efficacy and Safety of 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\n1. Age 18 to 80 years (inclusive), regardless of gender.\n2. Patients with cirrhosis confirmed by clinical, laboratory, imaging examinations, and\u002For liver biopsy.\n3. Hepatic venous pressure gradient (HVPG) ≥ 10 mmHg.\n4. Agree to participate and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Use of non-selective beta-blockers such as Carvedilol, Propranolol, or Alverine, Papaverine, and their derivatives (e.g., Papaverine Hydrochloride, Drotaverine Hydrochloride) within 4 weeks prior to enrollment.\n2. Previous surgeries including transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation.\n3. History or current occurrence of overt hepatic encephalopathy, esophagogastric variceal bleeding, or grade 3 ascites.\n4. Use of vasoactive drugs such as somatostatin and its analogs, vasopressin, terlipressin, dopamine, norepinephrine within 1 week prior to enrollment.\n5. History of heavy alcohol consumption within 12 weeks prior to enrollment and inability to abstain from heavy drinking during the study (equivalent to ethanol intake ≥30 g\u002Fday for males, ≥20 g\u002Fday for females).\n6. Serum total bilirubin level ≥3×ULN (≥5×ULN for autoimmune liver disease patients), or serum sodium level \\\u003C125 mmol\u002FL, or white blood cell count \\\u003C1×10\\^9\u002FL, or platelet count \\\u003C30×10\\^9\u002FL, or International Normalized Ratio (INR) \\>2.3.\n7. Significant renal insufficiency (eGFR (CKD-EPI formula) \\\u003C20 mL\u002Fmin\u002F1.73 m²).\n8. Presence of thrombosis or cavernous transformation in the portal venous system (including portal vein, splenic vein, superior mesenteric vein); patients with a history of portal vein thrombosis can be enrolled if no definite thrombosis is detected in the portal venous system within 2 weeks.\n9. HBV DNA or HCV RNA \\> the lower limit of detection; patients with active HCV antiviral treatment; patients on anti-HBV treatment for less than 24 weeks.\n10. Uncontrollable active infections (such as lung infection, abdominal infection, HIV, etc.) within 4 weeks prior to enrollment.\n11. Poorly controlled hypertension, diabetes, or other severe heart or lung diseases.\n12. Diagnosed or suspected malignancies, including liver cancer.\n13. Known allergy to Alverine, Papaverine and their derivatives (e.g., Papaverine Hydrochloride, Drotaverine Hydrochloride) or Carvedilol; contraindications for Carvedilol: NYHA class IV decompensated heart failure requiring intravenous inotropic drugs; asthma, chronic obstructive pulmonary disease (COPD) with bronchospasm; second or third degree atrioventricular block, severe bradycardia (heart rate less than 50 bpm), sick sinus syndrome (including sinoatrial block); cardiogenic shock; severe hypotension (systolic blood pressure less than 85 mmHg).\n14. Patients with glaucoma.\n15. Patients with psychiatric disorders.\n16. Pregnant or lactating women, or women with potential for pregnancy.\n17. Participation in other drug trials within 4 weeks prior to enrollment.\n18. Other reasons deemed unsuitable by the researchers.",{"count":167,"type":20},178,[98,121],"Study Overall Design:\n\nThis trial is a prospective, open-label, multicenter, randomized controlled clinical trial. Subjects who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to either the Alverine treatment group or the Carvedilol treatment group in a 1:1 ratio after signing the informed consent form. After randomization, participants will enter a 24-week medication period. Apart from the baseline period, the efficacy of the treatment will be evaluated 24 weeks post-treatment. The safety evaluation will be conducted according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by the National Cancer Institute.\n\nStudy Population:\n\nPatients with cirrhotic portal hypertension.\n\nInterventions:\n\nAlverine Group: 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\u002Fday (1 capsule orally, 3 times a day), taken continuously for 24 weeks.\n\nCarvedilol Group: Jinluo (Carvedilol Tablets; 6.25 mg; manufactured by Qilu Pharmaceutical Co., Ltd.), taken orally, starting dose of 6.25 mg once a day, gradually adjusted according to heart rate to 6.25 mg twice a day, 12.5 mg in the morning and 6.25 mg in the evening, 12.5 mg twice a day, or adjusted to the maximum tolerated dose (heart rate greater than 55 beats\u002Fmin and systolic blood pressure greater than 90 mmHg), taken continuously for 24 weeks.\n\nStudy Objectives:\n\n1. Primary Study Objective Evaluate the efficacy and safety of Compound Alverine Citrate Capsules in the treatment of cirrhotic portal hypertension.\n2. Secondary Study Objectives Evaluate the effect of Compound Alverine Citrate Capsules on the incidence of esophagogastric variceal bleeding and other cirrhotic decompensation events.\n3. Exploratory Study Objectives Evaluate the efficacy of Compound Alverine Citrate Capsules in the treatment of cirrhotic portal hypertension using other non-invasive detection methods. Observe the effects of Compound Alverine Citrate Capsules on the multi-omics characteristics of cirrhosis, reversal of portal hypertension, recompensation of decompensated cirrhosis, and prevention of the progression of cirrhosis to liver cancer.\n\nStudy Endpoints:\n\n(1) Primary Study Endpoints\n\n1. The treatment response rate, defined as a reduction in HVPG of ≥10% from baseline or a reduction to below 12 mmHg after 24 weeks of treatment.\n2. The incidence, events, and severity of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment (evaluated according to CTCAE version 5.0).\n\n(2) Secondary Study Endpoints\n\n1. Incidence of esophagogastric variceal bleeding during treatment.\n2. Incidence of other cirrhotic decompensation events (new onset or progression of ascites, spontaneous bacterial peritonitis, overt hepatic encephalopathy, acute kidney injury\u002Fhepatorenal syndrome, primary liver cancer, etc.) during treatment.\n3. Reduction in HVPG from baseline after 24 weeks of treatment.\n4. Mortality\u002Fliver transplantation rate during treatment.\n5. Overall survival time of subjects.\n6. Reduction in mean arterial pressure (MAP) and heart rate from baseline after 24 weeks of treatment.\n\n(3) Exploratory Study Endpoints\n\n1. Changes in liver stiffness and spleen stiffness from baseline after 24 weeks of treatment.\n2. Improvement in liver function (Child-Pugh score, MELD score) after 24 weeks of treatment.\n3. Changes in cardiac function (left ventricular ejection fraction) from baseline after 24 weeks of treatment.\n4. Changes in imaging characteristics, blood\u002Fstool metabolomics characteristics, portal hypertension reversal biomarkers, cirrhosis recompensation biomarkers, and cirrhosis progression to liver cancer biomarkers after 24 weeks of treatment.\n\nSample Size Calculation:\n\nIn animal experiments, it was confirmed that there was no statistically significant difference in the effect of Alverine and Carvedilol in treating portal hypertension. Literature reports indicate that the treatment response rate of Carvedilol for cirrhotic portal hypertension is approximately 60%. Based on the sample size calculation method for non-inferiority trials with two samples, with a non-inferiority margin δ=0.20, a one-sided α=0.025, and β=0.2, the calculated sample size for each group is 74 cases, totaling 148 cases. Considering a 20% dropout rate, a total of 178 cases are needed.",[28],[125,126,127],"2024-06-17",{"date":174,"type":38},"2024-06-24",{"date":155,"type":20},{"date":177,"type":20},"2025-11",{"name":137,"class":45}]