[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute of Liver and Biliary Sciences, India\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":542},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,42,64,85,108,132,156,175,191,213,231,252,272,293,312,330,351,367,385,401,426,453,476,497,519],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100644343","effect-of-ursodeoxycholic-acid-supplementation-on-liver-regeneration-in-adult-living-donor-liver-transplant-ldlt-recipients-100644343",false,"NCT07664020","Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients.","Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients : A Placebo Controlled Randomised Trial","Inclusion Criteria:\n\nAll Adult Living Donor Liver Transplant (LDLT) Recipients in ILBS from ethical board clearance to December 2027 in the Department of HPB Surgery and Liver Transplantation, Institute of Liver and Biliary Sciences\n\nExclusion Criteria:\n\n* Unwillingness to participate\n* Hypersensitivity to UDCA\n* Patients receiving UDCA pre-operatively within 1 month of liver transplant (PBC and patients of overlap syndrome)\n* Right posterior and left laterals grafts\n* Emergency Liver Transplant","ALL","18 Years","70 Years",{"count":21,"type":22},130,"ESTIMATED","INTERVENTIONAL",[25],"NA","This placebo controlled randomized control study aims to analyze the effect of UDCA supplementation on liver regeneration in Living Donor Liver Transplant (LDLT) recipients. All eligible LDLT recipients during the study period will be included in the study and randomized into two groups. One group will receive Tab UDCA starting atleast 10 days pre-operatively and continued till post-operative day 10 and the other group will receive placebo. UDCA will be given at a dose of 15mg\u002Fkg per day in two divided doses. Recipients who are not willing to participate in the study, have hypersensitivity to UDCA will be excluded from the study. Pediatrics recipients and acute liver failure recipients will also be excluded.\n\nPre- operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system (PACS). The enrolled subjects will be followed up till for a period of 14 days after the transplant till NCCT Abdomen is done and regenerated liver volumes are analyzed. The anatomic(volumetric), functional(liver function tests) and regenerative biomarkers (HGF, TNF-Alpha, IL6, TGF-Beta1) will be compared between the two groups. Evaluation of incidence of Early Allograft Dysfunction (EAD) as per Modified Olthoff criteria1 will be done between the two groups. FXR receptor concentration (hepatocytes) and TGR-5 receptor concentration (cholangiocytes) will be seen in the explant liver along with evaluation of monocyte number and function and mitochondrial and nuclear DNA.",[28],"Chronic Liver Disease","NOT_YET_RECRUITING","2026-06-17",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":22},"2026-06-18",{"date":37,"type":22},"2027-11-01",{"name":39,"class":40},"Institute of Liver and Biliary Sciences, India","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100602065","host-diet-gut-interaction-post-vegan-diet-in-pediatric-autoimmune-hepatitis-100602065","NCT07118657","Host-Diet-Gut Interaction Post Vegan Diet in Pediatric Autoimmune Hepatitis.","Inclusion Criteria:\n\n1. Cases diagnosed as Autoimmune hepatitis (AIH).\n2. Controls are healthy subjects.\n\nExclusion Criteria:\n\n1. Recent (\\\u003C 6 weeks) exposure to oral or intravenous antibiotics, probiotics\u002Fprebiotics, proton pump inhibitors, or herbal medicines.\n2. Any history of malignancy or any gastrointestinal tract surgery.\n3. Recent (\\\u003C 2 weeks) gastrointestinal infection.\n4. Any dietary allergies .","0 Years",{"count":50,"type":22},40,[25],"Pediatric autoimmune liver diseases (AILDs), including autoimmune hepatitis (AIH) and overlap syndromes like sclerosing cholangitis, are among the most common chronic liver conditions in the pediatric population. Currently, the treatment for AIH often involves long-term use of immunosuppressive therapy, which carries risks of severe side effects both in the short and long term. Due to these potential adverse effects, there is a critical need to explore alternative therapies that can modulate autoimmunity and potentially reduce or eliminate the dependence on immunosuppressive drugs. Autoimmune diseases, including AIH, typically arise in genetically predisposed individuals after exposure to certain environmental factors, leading to a breakdown in self-tolerance.The gut microbiome plays a crucial role in modulating the immune system through both anti-inflammatory and pro-inflammatory pathways. In advanced liver diseases, factors such as intestinal dysmotility, small intestinal bacterial overgrowth (SIBO), and increased intestinal permeability contribute to enhanced bacterial translocation, consistent with the \"leaky gut\" hypothesis. This phenomenon allows the passage of toxins, antigens, and bacteria into the systemic circulation, potentially exacerbating autoimmune responses. Consequently, altering the gut microbiome through dietary changes, probiotics, prebiotics, or fecal microbiota transplantation presents a promising therapeutic approach for autoimmune diseases.This study aims to investigate the gut microbiome and its modification following dietary intervention (specifically, a plant-based vegan diet) in pediatric AIH. Additionally, investigator will explore the potential role of such interventions in managing intestinal dysfunction in patients with advanced liver disease. In Aim 1, investigator will compare the baseline gut microbiome profiles of treatment-naïve pediatric AIH patients with those of healthy, age- and sex-matched controls to provide foundational insights. In Aim 2, investigator will evaluate the proportion of patients achieving biochemical remission after 180 days of a vegan versus standard diet in AIH patients. Investigator will also assess changes in stool metagenomics, metabolomics, cytokine profiles, gut epithelial barrier function, and liver disease severity scores between the two dietary groups.\n\nThis study aims to demonstrate the potential benefits of a vegan diet in managing autoimmune hepatitis. It seeks to provide evidence supporting dietary modifications as a complementary approach to standard medical treatments for a wide range of autoimmune or autoimmune-like disorders, potentially paving the way for future therapeutic strategies.",[54],"Autoimmune Hepatitis","RECRUITING","2026-06-10",{"date":58,"type":33},"2026-06-12",{"date":60,"type":33},"2026-02-11",{"date":62,"type":22},"2028-04-30",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":41},"100593160","effect-of-single-vs-repeated-cycles-of-a-combination-of-granulocyte-colony-stimulating-factor-and-darbepoetin-vs-standard-medical-treatment-on-immunometabolic-profile-in-patient-with-early-decompensated-cirrhosis-100593160","NCT07002827","Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis.","Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis -A Pilot Randomised Controlled Trial.","Inclusion Criteria:\n\n1. Age 18-70 years\n2. Decompensated cirrhosis patients\n3. Uncomplicated ascites,\n4. CTP ≤ 9B and MELD \\\u003C16\n5. BM Hematopoietic stem cell reserve \\> 0.4\n6. Given informed consent\n\nExclusion Criteria:\n\n1. Patients with age less than 18 years or more than 65 years\n2. Lack of informed consent\n3. Patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients\n4. Evidence of alcoholic hepatitis\u002Factive alcohol abuse last intake ≤ 3 months\n5. Suspected autoimmune hepatitis (ANA\u002FASMA-positive in titers 1:80 and\u002F or IgG 1.5 times upper limit of normal),\n6. Hemolytic anaemia -Sickle cell disease or thalassemia\n7. Patients with Grade III ascites \u002Fcomplicated ascites\n8. Patients with large spleen (size ≥ 15cm)\n9. Recent variceal bleeding in less than 42 days\n10. Patients with any focus of sepsis as proven by culture positivity or presence of spontaneous Bacterial Peritonitis (SBP)\n11. H\u002Fo Seizures\n12. Hepatocellular Carcinoma (HCC) or other malignancy\n13. Acute Kidney Injury (AKI) with serum Creatinine \\>1.5 mg\u002F dl,\n14. Multi-organ failure,\n15. Hepatic Encephalopathy or prior history of HE in less than 6months\n16. HIV seropositivity,\n17. Uncontrolled essential hypertension, CAD \u002FStroke\n18. Massive hydrothorax\n19. Pregnancy\n20. Viral etiology of liver disease\n21. Chronic kidney disease\n22. Portal vein thrombosis\n23. Planned for LT\n24. Bone marrow hematopoietic stem cells \\\u003C 0.4",{"count":72,"type":22},60,[25],"Exogenous growth factor-mobilized bone marrow (BM) stem cells(G-CSF) and DARBEPOETIN use have shown a differential response in the management of decompensated cirrhosis (DC) with improved survival, CTP and MELD scores. This study was designed to evaluate potential clinical benefit of repeated cycles of granulocyte-colony stimulating factor (G-CSF) and DARBEPOETIN versus single cycle on delta change in immunometabolic profile of patients at 6 months assessed in terms of -Change in innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation .",[76],"Decompensated Liver Cirrhosis","2026-05-19",{"date":79,"type":33},"2026-05-22",{"date":81,"type":33},"2025-06-04",{"date":83,"type":22},"2026-12-30",{"name":39,"class":40},{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":41},"100638111","safety-and-efficacy-of-finerenone-in-metabolic-dysfunction-associated-steatotic-liver-diseasemasldnafld-related-cirrhosis-patients-with-ascites-in-prevention-of-chronic-kidney-disease-100638111","NCT07585526","Safety and Efficacy of Finerenone in Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD\u002FNAFLD) Related Cirrhosis Patients With Ascites in Prevention of Chronic Kidney Disease.","Safety and Efficacy of Finerenone in Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD\u002FNAFLD) Related Cirrhosis Patients With Ascites in Prevention of Chronic Kidney Disease. A Randomized Control Trial.","Inclusion Criteria:\n\n1. Age \\> 18 years \\\u003C80years\n2. Patient of MASLD\u002F NAFLD cirrhosis with clinical ascites\n3. Stable eGFR-(\\>60 ml\u002Fmin\u002F1.73m2) calculated using MDRD-6 equation: eGFR (ml\u002Fmin\u002F1.73 m2) = 170 × (Scr)-0.999 × (Age)-0.176 × (0.762 if patient is female) × (1.180 if black) × (SUN)-0.170 × (Albumin)0.318\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years \\>80 years\n2. K\u002FC\u002FO systemic hypertension.\n3. Coagulopathy- INR \\>2.5\n4. Post TIPS\n5. CTP class C\n6. Any intrinsic\u002Fstructural kidney disease.\n7. Refractory Ascites\n8. Patient with HCC(outside MILAN criteria) or portal vein thrombosis\n9. Pregnancy or Lactating mother\n10. Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment\n11. Patients with anuria, acute renal failure, or Addison's disease\n12. Heart failure (NYHA II to IV)\n13. History of hospitalization for hyperkalaemia or acute renal failure induced by previous aldosterone antagonist treatment\n14. Ongoing drug or alcohol abuse\n15. Uncontrolled type 2 DM ( HbA1C \\> 9)\n16. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment\n17. Coronary revascularization (percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]) or valvular repair\u002Freplacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomisation\n18. Diagnosed Mixed ascites (additional etiology of ascites apart from portal hypertension)\n19. Patients who are on spirinolactone with stable ascites in the past 12 weeks\n20. Refusal to give consent","80 Years",{"count":94,"type":22},160,[25],"Renal dysfunction is a frequent and clinically important complication in cirrhosis, and MASLD\u002FNAFLD is associated with increased risk of incident CKD; however, finerenone has not been specifically studied in MASLD-cirrhosis populations despite proven cardiorenal benefits in diabetic CKD. This monocentric, open-label, randomized controlled trial at the Department of Hepatology, ILBS, New Delhi will enroll 160 adults (18-80 years) with MASLD\u002FNAFLD cirrhosis, clinical grade I-II ascites, and stable eGFR ≥60 mL\u002Fmin\u002F1.73 m² (MDRD-6), with key exclusions including CTP class C, refractory ascites, significant coagulopathy, intrinsic kidney disease, recent major cardiovascular events, and other protocol-defined contraindications. Participants will receive standard medical treatment (dietary measures, diuretics as indicated, metabolic control, complication management, albumin\u002Fbeta-blockers as needed) and will be randomized to finerenone (5 mg\u002Fday uptitrated to 10-20 mg\u002Fday) versus spironolactone (50 mg\u002Fday uptitrated to 100-200 mg\u002Fday). The primary endpoint is incident CKD at 6 months , defined as sustained eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m² over 3 months. Secondary endpoints include MAKE\u002FMACE\u002FMALO at 6 months, drug-related adverse events (including hyperkalemia, hyponatremia, hypotension, hyperuricemia), AKI\u002FAKD episodes, renal biomarkers (e.g., cystatin C, UPCR), ascites response, liver severity scores (MELD 3.0\u002FMELD-Na\u002FCTP), and metabolic\u002Finflammatory\u002Fendothelial markers (e.g., HbA1c, HOMA-IR, hsCRP, vWF). Sample size (n=160; 80\u002Farm) is powered to detect an absolute 20% reduction in CKD progression (35% to 15%) with 80% power and 5% alpha (10% dropout), with intention-to-treat analyses including Kaplan-Meier and Cox regression methods.",[98,99],"MASLD","Chronic Kidney Diseases","2026-05-09",{"date":102,"type":33},"2026-05-13",{"date":104,"type":22},"2026-04-15",{"date":106,"type":22},"2028-03-31",{"name":39,"class":40},{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":4},"100607154","vitamin-c-for-acute-kidney-injury-in-aclf-with-septic-shock-a-randomized-controlled-trial-100607154","NCT07184866","Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial","A Randomized Controlled Trial Open Label Evaluating the Efficacy of Vitamin C in Improving Outcomes of Acute Kidney Injury in Patients With ACLF With Septic Shock","VITAKI-ACLF","Inclusion Criteria:\n\n* ACLF as per asia pacific association for the study of liver (APASL criteria) with AKI according to KDIGO Criteria and septic shock.\n\nExclusion Criteria:\n\n* • Refractory Septic shock with more than 3 organ failures.\n\n  * Patients with age less than 18 years\n  * Known severe cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)\n  * Patients in DIC with platelets \\\u003C 20,000 and INR \\> 4 or active bleeding\n  * Limitations of care (defined as refusal of cardiovascular and respiratory support modes) including \"do not intubate\" (DNI) status\n  * Current hospitalization \\> 15 days for patients with nosocomial acquisition of MDR at time of randomization\n  * Known allergy or contraindication to vitamin C (including previously or currently diagnosed primary hyperoxaluria and\u002For oxalate nephropathy, or known\u002Fsuspected ethylene glycol ingestion,\n  * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency)\n  * Use of vitamin C at a dose of \\> 1 gram daily within the 24 hours preceding first episode of qualifying organ dysfunction during a given ED or ICU admission\n  * Patients with HCC (beyond Milan) or extrahepatic malignancies\n  * Patients with HVOTO or EHPVO\n  * Pregnancy or active breastfeeding\n  * Current participation in another interventional research study\n  * Active or history of kidney stones\n  * History of chronic kidney disease or intrinsic kidney disease\n  * Patients already on maintenance hemodialysis prior to presentation\n  * Failure to provide informed consent\n  * Patients with retroviral infection\n  * Patients with active hemolysis due to alcohol or other causes or with hemoglobin below 7 gm\u002Fdl",{"count":117,"type":22},110,[25],"This study is testing whether Vitamin C can help improve kidney function and survival in very sick patients with liver disease. Patients with acute-on-chronic liver failure (ACLF) often develop serious infections that can lead to septic shock and kidney injury, which are major causes of death.\n\nIn this randomized controlled trial, patients with ACLF and septic shock will be assigned to receive either:\n\n1. Standard medical treatment alone, or\n2. Standard medical treatment plus intravenous Vitamin C.\n\nVitamin C is a safe, inexpensive antioxidant that may reduce inflammation, improve circulation, and protect the kidneys. The study will compare how well patients recover from septic shock and kidney injury in the two groups. Blood and urine samples will also be collected to look for biological markers that can predict outcomes.",[121],"Acute-on-Chronic Liver Failure (ACLF)",[123],"Sepsis, septic shock, Alcohol-related, ACLF, AKI, Lactate, Vitamin","2026-03-24",{"date":126,"type":33},"2026-03-25",{"date":128,"type":22},"2026-04",{"date":130,"type":22},"2027-10",{"name":39,"class":40},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":155,"locationsCount":4},"100606654","double-plasma-separation-and-adsorption-in-acute-on-chronic-liver-failure-dpmas-aclf-trial-100606654","NCT07178366","Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)","Impact of Double Plasma Separation and Adsorption on Patients With Acute on Chronic Liver Failure- A Prospective Open-label Randomized Controlled Trial","DPMAS-ACLF","Inclusion Criteria:\n\n* ACLF patients of any etiology with systemic inflammatory response syndrome and AARC grade II or more.\n\nExclusion Criteria:\n\n* Patients eligible for corticosteroids for severe alcohol-associated hepatitis related ACLF (other than hydrocortisone according to Surviving Sepsis Campaign Guidelines 2021 which is 50 mg iv q 6 h for management of refractory shock\n* Hepatocellular carcinoma or any extrahepatic malignancy,\n* Active fungal sepsis\n* Disseminated intravascular coagulation\n* Hemodynamic instability requiring norepinephrine \\>0.20ug\u002Fkg\u002Fmin\n* Patients with coma of non-hepatic origin\n* Patients with PaO2\u002FFiO2 ratio \\\u003C150\n* Pregnancy\n* Comorbidities associated with poor outcomes (severe cardiopulmonary disease defined by a New York Heart Association score \\>3, or oxygen\u002Fsteroid-dependent chronic obstructive pulmonary disease, chronic kidney disease) and patients with post-resection liver failure\n* Patients with fibrinogen \\\u003C110 and\u002For platelets less than 50,000\n* Patients with oliguria with urine output less than 400 ml\u002Fday\n* Lack of informed consent\n* Patient enrolled in other clinical trials",{"count":141,"type":22},56,[25],"Acute-on-chronic liver failure (ACLF) is a serious condition in which patients with chronic liver disease suddenly develop severe liver injury, leading to inflammation, organ failure, and very high short-term mortality. Standard medical treatment can help, but many patients still do poorly without liver transplantation.\n\nThis study will test whether Double Plasma Molecular Adsorption System (DPMAS), an extracorporeal blood purification therapy, can improve outcomes in ACLF patients. DPMAS works by filtering the blood through special adsorption columns that remove harmful substances such as bile acids, toxins, and inflammatory molecules.\n\nIn this randomized controlled trial, adult patients with ACLF will be randomly assigned to receive either:\n\nStandard medical therapy alone, or\n\nStandard medical therapy plus DPMAS.\n\nThe main goal is to see whether DPMAS can improve liver function and reduce disease severity within 14 days. Other outcomes include survival without liver transplant at 28 days, improvement in organ functions, reduction in inflammation, and safety of the procedure.\n\nThe study will be conducted at the Institute of Liver and Biliary Sciences (ILBS), New Delhi, India, and will enroll about 56 participants over one year.",[121],[146,147,148,149,150],"ACLF","DPMAS","Lactate","Sepsis","Liver support",{"date":126,"type":33},{"date":153,"type":22},"2026-05-10",{"date":130,"type":22},{"name":39,"class":40},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":172,"leadSponsor":174,"locationsCount":41},"100629852","assessment-of-changes-in-bone-mineral-metabolism-after-liver-transplantation-by-bone-mineral-densitometry-100629852","NCT07480057","Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry","Inclusion Criteria:\n\n\\- All adult patients \\>18 yrs with Cirrhosis of Liver undergoing Live Donor Liver Transplant\n\nExclusion Criteria:\n\n1. Patients not giving consent.\n2. LT for ALF\n3. Pediatric LT recipients\n4. DDLT recipients",{"count":163,"type":22},100,"OBSERVATIONAL","Liver transplantation (LT) remains the ultimate option to cure intractable end stage liver disease. Nutritional deficiencies are very common among CLD patients and due to this these patients suffer from low bone mineral density leading to osteoporosis and osteopenia. It has been observed that there is substantial reduction in bone density , especially within the first year of LT. The incidence of fractures among LT recipients has been reported to be around 3.5% with vertebral spine being the most common site. Multiple risk factors for osteoporosis after LT has been identified. Some of these include female sex, DM, sedentary lifestyle, pretransplant hypogonadism, Vit-D deficiency and pre-existing bone mineral abnormalities. Patients with CLD are also reported as having osteoblastic dysfunction by many factors, like unconjugated hyperbilirubinemia, decreased synthesis of collagen matrix, and decreased availability of insulin like growth factors. Post-transplant factors among LT recipients include: choice of immunosuppressive therapy like Glucocorticoid and CNIs therapy.\n\nThis Observational study aims to analyze the changes in bone mineral metabolism After Liver Transplantation by Bone Mineral Densitometry preoperatively and postoperatively. All eligible adult patients with Chronic Liver Disease undergoing Liver Transplant during the study period will be included in the study. These patients bone mineral density will be assessed using DEXA scan both preop and on Post op at 3 and 6 months. The association between the changes in BMM and various variables such as the sex of the patients, age of patients, etiology of CLD, presence of hepatocellular carcinoma (HCC), ICU stay, Hospital stay will be studied.\n\nPre-operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system(PACS). The enrolled subjects will be followed up till for a period of 6 months after the Liver Transplant and the bone mineral density will be compared between these patients along with other parameters.",[167],"Chronic Liver Disease and ACLF","2026-03-18",{"date":170,"type":33},"2026-03-19",{"date":168,"type":33},{"date":173,"type":22},"2026-10-30",{"name":39,"class":40},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":189,"leadSponsor":190,"locationsCount":41},"100629848","to-revisit-the-yield-of-staging-laparoscopy-in-hepatopancreatobiliary-malignancies-100629848","NCT07480005","To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies","Inclusion Criteria:\n\n\\-\n\nAll patients with suspected HPB malignancies undergoing staging laparoscopy before proceeding to laparotomy.\n\nPre-op CT scans of cut size less than or equal to 1.5 mm\n\nExclusion Criteria:\n\n1. Patients undergoing staging laparoscopy without intent of curative resection in the same sitting.\n2. malignancies other than adenocarcinoma\n3. Final histopathology is benign",{"count":182,"type":22},350,"This research project, to be conducted at the Institute of Liver \\& Biliary Sciences, aims to evaluate the effectiveness of staging laparoscopy (SL) in detecting occult metastases in hepatopancreatobiliary (HPB) malignancies in the current era of advanced imaging modalities such as MDCT, MRI, EUS, and PET-CT. While SL is a minimally invasive technique that aids in identifying radiologically undetectable metastases, its utility in routine practice is under scrutiny due to improved imaging accuracy. The study is premised on the hypothesis that the yield of SL is low in the current imaging era, questioning its routine application.\n\nThe study uses an ambispective cohort design and includes all patients undergoing SL for HPB malignancies from January 2012 to March 2026 at ILBS, Delhi. The primary objective is to assess the yield of SL, while secondary objectives include evaluating false positives\u002Fnegatives, the added value of PET-CT over CT, and identifying clinical or radiological predictors of positive SL.\n\nSubgroup analyses will be performed for different HPB cancers including periampullary malignancies, gallbladder cancer, hilarcholangiocarcinoma, intrahepatic cholangiocarcinoma, pancreatic ductal adenocarcinoma, and hepatocellular carcinoma. Data collection includes demographics, tumor markers, imaging findings, SL results, duration, and associated costs.\n\nFindings from this study could inform refined criteria for the selective use of SL, avoiding unnecessary surgeries and optimizing resource utilization. This could lead to evidence-based guidelines for staging practices in HPB cancers, balancing clinical benefits against costs and surgical risks in the context of modern diagnostic capabilities.",[185],"HPB Malignancies",{"date":187,"type":33},"2026-03-23",{"date":168,"type":33},{"date":173,"type":22},{"name":39,"class":40},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":41},"100628732","carvedilol-and-midodrine-versus-carvedilol-alone-in-preventing-early-rebleed-in-patients-with-cirrhosis-100628732","NCT07465471","Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis.","Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis: A Randomized Controlled Trial.","Inclusion Criteria:\n\n1. Consecutive patients of cirrhosis with high-risk acute variceal bleed (Child-Pugh class B \\> 7 with active bleeding at initial endoscopy or Child-Pugh class C \\\u003C 14 points).\n\nExclusion Criteria:\n\n1. Age less than 18 years or \\> 75 years.\n2. HR \\\u003C 60\u002F min and BP \\\u003C 100\u002F60 mm Hg\n3. Child-Pugh's score \\\u003C8 and \\>13.\n4. MELD score \\>30 and serum lactate \\>12mmol\u002FL.\n5. Refractory variceal bleed.\n6. Preemptive TIPS or previous Porto-systemic shunt or TIPS.\n7. Non-selective Beta blocker\u002Fcarvedilol \u002F midodrine treatment in last 5 days.\n8. Acute kidney injury - HRS.\n9. Uncontrolled Hypertension (BP \\> 140\u002F90 mmHg), heart block, congestive heart failure.\n10. Contraindication to NSBB (HR\\\u003C60\u002Fmin, BP\\\u003C90\u002F60mmHg, bronchial asthma).\n11. Hepatocellular carcinoma (outside Milan criteria), extrahepatic malignancy.\n12. Pregnant women.\n13. Bleeding from isolated gastric or ectopic varices.","75 Years",{"count":200,"type":22},210,[25],"Acute variceal bleeding (AVB) in cirrhosis occurs as a result of portal hypertension and carries a 6-week mortality rate of approximately 10-20%. Standard management includes a restrictive transfusion approach, vasoactive therapy, prophylactic antibiotics, and endoscopic band ligation. Despite this, early rebleeding within the first 5 days still occurs in about 10-20% of patients, and individuals at particularly high risk may benefit from pre-emptive TIPS. However, its real-world use remains limited; one study reported that only 6.7% of eligible patients actually underwent pre-emptive TIPS, primarily due to logistical challenges and limited interventional radiology availability for early, non-emergent TIPS procedures.\n\nMidodrine, an oral and fast-acting selective α1-adrenergic agonist, has been shown to enhance the effectiveness of nonselective beta-blockers like propranolol by allowing higher tolerated doses and achieving greater reductions in portal pressure (HVPG), thereby reducing the risk of initial variceal bleeding. However, no studies have evaluated the combination of midodrine with carvedilol-currently a preferred agent-versus carvedilol alone in patients at high risk of rebleeding.\n\nTo address this gap, we propose a study comparing carvedilol plus midodrine with carvedilol alone for preventing early rebleeding in cirrhotic patients. Individuals with cirrhosis (Child-Pugh 8-13) presenting with hematemesis will be enrolled, stabilized according to APASL guidelines, and after 48 hours randomized to either combined midodrine-carvedilol therapy or carvedilol alone. Participants will be followed for 6 weeks to assess the incidence of early rebleeding.",[204],"Liver Cirrhosis","2026-03-06",{"date":207,"type":33},"2026-03-12",{"date":209,"type":22},"2026-03-01",{"date":211,"type":22},"2027-09-30",{"name":39,"class":40},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":230,"locationsCount":41},"100626303","serosurvey-of-hav-immunity-and-single-dose-vaccine-immunogenicity-among-patients-with-cirrhosis-100626303","NCT07433881","Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis","Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis.","Inclusion Criteria:\n\n1. \\>18 years of age with cirrhosis.\n2. Anti-HAV IgG negative at screening.\n3. No prior HAV vaccination.\n\nExclusion Criteria:\n\n1. Unable\u002Funwilling to consent.\n2. Pregnant patients.\n3. Clinically unstable.",{"count":221,"type":22},360,"Hepatitis A virus (HAV) superinfection in patients with cirrhosis can precipitate acute hepatic decompensation and significantly worsen outcomes. Although HAV exposure was historically universal in India, recent evidence shows declining natural immunity in adults, particularly in urban populations. Contemporary data on HAV seroprevalence and vaccine immunogenicity in Indian cirrhotics remain scarce. Updated evidence is necessary to inform national vaccination policy for chronic liver disease.\n\nThis study aims to estimate the prevalence of anti-HAV IgG among adults with cirrhosis and identify predictors of non-immunity. A secondary objective is to evaluate early immunogenicity and durability of a single dose of inactivated HAV vaccine in baseline non-immune patients.\n\nThis study will generate updated sero-epidemiological data and prospective evidence on single-dose HAV vaccine immunogenicity in Indian cirrhotics, providing essential guidance for HAV vaccination policies in cirrhosis.\n\nSTUDY DESIGN: Observational cross-sectional study with a nested prospective cohort.",[204],"2026-02-19",{"date":226,"type":33},"2026-02-25",{"date":226,"type":22},{"date":229,"type":22},"2027-02-27",{"name":39,"class":40},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":41},"100625462","efficacy-and-safety-of-early-initiation-of-midodrine-for-control-and-prevention-of-ascites-and-its-related-complications-in-acute-on-chronic-liver-failure-100625462","NCT07422948","Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure.","Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure: A Randomized Controlled Trial.","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. ACLF\n3. Ascites (Grade II\u002FIII).\n4. Willing\u002Fable for salt restriction, labs, urine collections, and follow-ups; consent obtained.\n\nExclusion Criteria:\n\n1. SCr ≥ 1.5 mg\u002FdL OR ongoing AKI \\>stage I\n2. Persistent or uncorrectable severe hyponatremia (Na ≤120 mEq\u002FL), hyperkalemia (\\>6.0 mEq\u002FL) or any other critical electrolyte imbalance.\n3. Refractory ascites\n4. Spontaneous bacterial peritonitis\n5. Hepatic encephalopathy grade II-III.\n6. Shock, need for IV vasopressors, SBP \\\u003C90 mmHg or MAP \\\u003C65 despite fluids\u002Falbumin.\n7. Active GI bleed, uncontrolled infection\u002Fsepsis, or SBP at screening.\n8. Severe cardiomyopathy, critical valvular disease, arrhythmias contraindicating α-agonists.\n9. ACLF patients on Mechanical ventilation\u002FICU\u002Fionotropes\u002FHigh flow oxygen\n10. Pregnancy, lactation.\n11. Hypersensitivity\u002Fintolerance to midodrine.\n12. Significant LUTS.",{"count":239,"type":22},113,[25],"Ascites is a cardinal and debilitating complication in patients with acute-on-chronic liver failure (ACLF), significantly correlating with disease severity and poor prognosis. The underlying pathophysiology is driven by severe splanchnic arterial vasodilation, which reduces effective arterial blood volume and triggers compensatory neurohumoral activation. This cascade leads to profound sodium retention, renal vasoconstriction, and circulatory instability. Consequently, patients with ACLF frequently experience diuretic intolerance and are at elevated risk for severe complications, including electrolyte disturbances, acute kidney injury (AKI), and hepatorenal syndrome (HRS).\n\nCurrent management strategies rely heavily on diuretics and albumin; however, the efficacy of diuretics is often limited by systemic hypotension and pre-existing renal impairment, leading to frequent treatment failure or diuretic-induced complications. Existing clinical guidelines lack definitive recommendations regarding the preemptive use of vasoconstrictors to stabilize hemodynamics before ascites becomes refractory. Midodrine, an oral alpha-1 adrenergic agonist, targets this circulatory dysfunction by increasing systemic vascular resistance and improving renal perfusion. This randomized controlled trial aims to evaluate the efficacy and safety of the early initiation of midodrine in achieving better control of ascites and preventing the progression to renal complications in patients with acute-on-chronic liver failure.",[243],"Acute on Chronic Liver Failure","2026-02-13",{"date":246,"type":33},"2026-02-20",{"date":248,"type":22},"2026-02-05",{"date":250,"type":22},"2027-08-30",{"name":39,"class":40},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":41},"100623025","pathogenesis-of-chronic-kidney-disease-associated-with-metabolic-dysfunction--associated-fatty-liver-disease-mafld-and-treatment-response-of-oral-semaglutide-100623025","NCT07391267","Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide.","Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide - a Randomized Controlled Trial.","Inclusion Criteria:\n\n* 1.Age above or equal to 18 years at the time of signing informed consent. 2.Diagnosed with type 2 diabetes mellitus 3.HbA1c less than or equal to 10% (less than or equal to 86 mmol\u002Fmol) 4.Renal impairment defined either by:\n* serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL\u002Fmin\u002F1.73 m\\^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg\u002Fg or\n* serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL\u002Fmin\u002F1.73 m\\^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg\u002Fg 5.Treatment with maximum labelled or tolerated dose of a reninangiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening.\n\nExclusion Criteria:\n\n1. Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)\n2. Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).\n3. Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.\n4. Known or suspected excessive consumption of alcohol (greater than 20 g\u002Fday for women or greater than 30 g\u002Fday for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).\n5. Treatment with vitamin E (at doses greater than or equal to 800 IU\u002Fday) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening.\n6. Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A).\n7. Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.\n8. Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations\n9. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening.\n10. Presently classified as being in New York Heart Association (NYHA) Class IV heart failure\n11. Planned coronary, carotid or peripheral artery revascularisation\n12. Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis 13 Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupildilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n\n    \\-",{"count":260,"type":22},90,[25],"This project aims to investigate how Chronic Kidney Disease (CKD) develops and progresses in patients who also have Non-Alcoholic Fatty Liver Disease (NAFLD) and to evaluate whether oral semaglutide (a GLP-1 receptor agonist) can slow or prevent this progression.\n\nNAFLD and CKD frequently coexist due to shared mechanisms such as insulin resistance, inflammation, oxidative stress, dyslipidemia, and metabolic syndrome. Because of these overlapping pathways, a single therapy targeting both organs may offer major benefits.\n\nSemaglutide is known to reduce liver fat, improve inflammation and fibrosis, promote weight loss, and provide renal protection. This project will test whether adding oral semaglutide to standard care leads to better kidney and liver outcomes than standard care alone.\n\nThe study is designed as a randomised controlled trial conducted at ILBS, enrolling adults having NAFLD with CKD (with specific eGFR and albuminuria criteria). Participants will be followed for 2 years, with regular assessment of kidney function (eGFR, ACR), liver health (FibroScan, ALT\u002FAST), metabolic parameters, and cardiovascular outcomes.\n\nA parallel animal study in mice with diet-induced fatty liver disease will validate mechanistic findings through liver and kidney histology, gene expression, metabolic tests, and biochemical markers after semaglutide treatment.\n\nExpected outcome: To demonstrate that semaglutide slows CKD progression and improves NAFLD, supporting its use as a therapeutic option for patients with coexisting both conditions.",[99,264],"MAFLD","2026-01-29",{"date":248,"type":33},{"date":268,"type":22},"2026-02-01",{"date":270,"type":22},"2028-12-31",{"name":39,"class":40},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":279,"maxAge":18,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":41},"100580003","standard-volume-vs-high-volume-plasma-exchange-in-pediatric-acute-liver-failure-100580003","NCT06831643","Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure","Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure - A Pilot Randomized Control Trial","Inclusion Criteria:\n\n1. Age: 3 years to 18 years\n2. Fulfilling PALFSG definition (J Pediatr. 2006 May;148(5):652-658).\n3. Baseline INR ≥ 2.5, and increasing INR (any value) and\u002For worsening hepatic. encephalopathy (\\> 1 grade change) after 6 to 12 hours of standard medical therapy.\n\nExclusion Criteria:\n\n1. Disseminated intravascular coagulation\n2. Marked hemodynamic instability requiring a high dose of vasopressors (norepinephrine \\>0.5 mcg\u002Fkg\u002Fmin)\n3. Signs of irreversible brain injury\n4. Any severe cardio-pulmonary pre-existing disease\n5. Septic Shock","3 Years",{"count":50,"type":22},[25],"Acute liver failure is a multisystem disorder characterized by a syndrome of jaundice, coagulopathy, and encephalopathy with high mortality in the absence of liver transplantation. The pathogenesis of multiorgan failure (MOF) in ALF has been attributed to the release of damage-associated molecular patterns (DAMPs) from injured hepatic cells and microbial pathogen-associated molecular patterns (PAMPs) in the presence of superimposed infection or bacterial translocation.The innate immune cells activated by PAMPs and DAMPs produce pro-inflammatory cytokines \\[interleukin (IL)-6, IL-1b, IL-8, tumor necrosis factor-alpha (TNF-a)\\]. Studies indicate that the removal of inflammatory mediators appears to play a role in the treatment of ALF and are removed by some apheresis techniques. Hence therapeutic exchange (TPE) has been used as adjunct or standalone therapy for bridging patients to recovery or LT. TPE to treat liver failure involves two steps-removal of plasma from a patient with liver failure and replacing this with equal volume of fluid; in view of the coagulopathy seen in liver failure patients, the preferred fluid for replacement is fresh frozen plasma. Different doses of PLEX have been used to treat liver failure patients with high, standard or low volume PLEX, to treat ALF. Presently American Apheresis Society guidelines consider High Volume TPE (HV-TPE) as first line the management of ALF. But HV-TPE, apart from strain on blood bank resources (large volumes of fresh frozen plasma needed), also carries risk of transfusion associated acute lung complications, risk of blood borne virus infection, and so on make the use of low-volume PLEX attractive compared to high-volume PLEX. Hence this study is being carried out to consider the safety and efficacy of standard volume plasma exchange (SV-TPE) vs. HV-TPE in Pediatric ALF.",[284],"Acute Liver Failure","2025-12-31",{"date":287,"type":33},"2026-01-06",{"date":289,"type":33},"2025-02-17",{"date":291,"type":22},"2026-12-31",{"name":39,"class":40},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":300,"maxAge":18,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":311,"locationsCount":41},"100575125","effect-of-indianized-version-of-mediterranean-diet-vs-low-fat-diet-on-hepatic-steatosis-in-overweight-children-and-adolescent-with-masld-100575125","NCT06768216","Effect of Indianized Version of Mediterranean Diet vs. Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescent With MASLD","Effect of Indianized Version of Mediterranean Diet vs. Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescent With MASLD: A Randomized Control Trial","Inclusion Criteria:\n\n1. Age: 8-18 years\n2. BMI \\> 85th centile\n3. CAP \\> 236\n\nExclusion Criteria:\n\n\\- Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease.","8 Years",{"count":302,"type":22},134,[25],"NAFLD encompasses the entire spectrum of Fatty liver disease in individuals without significant alcohol consumption, ranging from fatty liver to steatohepatitis to cirrhosis. A high prevalence of NAFLD (62.5%) was observed in overweight\u002Fobese Indian adolescent (1). Lifestyle modification consisting of diet, exercise and weight loss has been advocated to treat patients with NAFLD (2). EASL guidelines recommends that the macronutrient in the diet should be adjusted according to the Mediterranean diet for weight loss (3). Mediterranean diet helps to decrease hepatic fat by decreasing lipogenesis, fibrogenesis, inflammation, oxidative stress and by increasing fatty acids beta oxidation (4). There are various studies showing benefits of using other diets such as Low Fat Diet, Low Carbdohydrate diet, Low Fructose Diet, et. Though there are numerous studies in adults comparing Mediterranean diet vs Low Fat diet, date regarding the same in children are lacking. The aim of this study will be to compare the Effect of Indianized version of Mediterranean diet vs. Low Fat Diet on Hepatic Steatosis in Overweight children and adolescent with MASLD.",[306],"Metabolic Dysfunction-Associated Steatotic Liver Disease",{"date":287,"type":33},{"date":309,"type":33},"2025-02-15",{"date":291,"type":22},{"name":39,"class":40},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":329,"locationsCount":41},"100615938","effect-of-whey-protein-versus-egg-albumen-protein-challenge-on-blood-ammonia-level-in-patients-of-decompensated-ethanol-related-cirrhosis-100615938","NCT07299110","Effect of Whey Protein Versus Egg Albumen Protein Challenge on Blood Ammonia Level in Patients of Decompensated Ethanol Related Cirrhosis.","Inclusion Criteria:\n\n1. Known or newly diagnosed (clinical, imaging) case of decompensated ethanol related cirrhosis patients.\n2. Age (18-70 years).\n3. Informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. History of overt HE (West Haven grade II or more).\n2. Last Intake \\\u003C1.5 months.\n3. CKD (creatinine \\>1.5 mg\u002FdL), active infection, GI bleeding in past 2 weeks.\n4. Severe anaemia (Hb \\\u003C7 g\u002FdL) or hypoalbuminemia (\\\u003C2.0 g\u002FdL).\n5. Known egg or dairy allergy.\n6. Those on sedatives, antidepressant or anti-psychiatric medication.\n7. Unable to understand the language or instructions.\n8. Hepatocellular Carcinoma.\n9. TIPS.\n10. Receiving rifaximin or lactulose.\n11. Diarrhea, SIBO or malabsorptive syndrome.",{"count":319,"type":22},50,[25],"In cirrhosis, altered nitrogen metabolism and reduced hepatic clearance of ammonia contribute to the development of Minimal Hepatic Encephalopathy (MHE)-a subclinical but functionally debilitating condition. While adequate protein intake is essential to prevent sarcopenia in cirrhotic patients, the type of protein consumed can significantly influence postprandial ammonia generation, thereby affecting neurocognitive status.\n\nThis study investigates the differential ammoniagenic potential of two commonly used high-protein nutritional supplements-Whey protein, which is rich in branched-chain amino acids (BCAAs) and rapidly absorbed, and egg albumen protein, which is slower digesting and higher in aromatic amino acids (AAAs), potentially more ammoniagenic.\n\nIn a crossover pilot design, 50 patients with decompensated ethanol-related cirrhosis will undergo two separate standardized protein challenges with 30g of each protein, spaced 24 hours apart. Venous ammonia levels and MHE parameters (via PHES\u002FStroop test) will be recorded pre- and 3 hours post-challenge.\n\nThe primary objective is to compare the change in blood ammonia between the two protein types. Secondary objectives include assessing MHE induction or worsening, and analysing the correlation between ammonia changes and cognitive decline.\n\nBy directly comparing the metabolic and neurocognitive response to distinct protein sources, this study will help inform safer dietary practices and refine nutritional supplementation in cirrhosis, especially for those at risk of hepatic encephalopathy.",[323],"Decompensated Cirrhosis Ethanol Related","2025-12-30",{"date":285,"type":33},{"date":327,"type":22},"2025-12-12",{"date":285,"type":22},{"name":39,"class":40},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":336,"maxAge":92,"enrollmentInfo":337,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":41},"100613167","time-to-post-operative-recovery-of-serum-albumin-as-a-predictor-of-outcome-in-major-hepato-pancreato-biliary-surgeries-100613167","NCT07263061","Time to Post-operative Recovery of Serum Albumin as a Predictor of Outcome in Major Hepato Pancreato Biliary Surgeries","Inclusion Criteria:\n\n1. All patients undergoing major Hepato pancreatico Biliary surgeries.\n2. Patients who are more than 12 years of age\n3. Retrospective arm - Data from 2010\n\nExclusion Criteria:\n\n1. Patients who refuse or are unable to give consent.\n2. Patients with Nephrotic syndrome, Protein losing enteropathies, Inflammatory bowel\n3. Disease, Chronic Liver Disease.\n4. Emergency Surgeries","13 Years",{"count":338,"type":22},1000,"Hepatobiliary and Pancreatic surgery is associated with substantial risk of postoperative complications. Albumin is a negative acute phase protein. Its rapid decline may be due to degree of inflammation due to surgical procedures. The decline may due to multifactorial causes. Currently, contemporary data regarding the time to recovery of albumin, as a marker for early recovery of patient from surgical stress is sparse. Delta albumin is influenced by perioperative fluid administration and albumin supplementation. Delta albumin may not reflect the true surgical stress. Early post op albumin is a reflection of intraoperative events and not postoperative recovery or events and is unpredictable. Shorter recovery time of albumin is associated with less post op complications and hospital stay. Earlier recovery of albumin predicts lower morbidity and shorter hospital stay.",[341,342,343],"Hepatobiliary Disease","Pancreas Disease","Bile Duct Diseases","2025-12-24",{"date":285,"type":33},{"date":347,"type":33},"2025-12-07",{"date":349,"type":22},"2026-10-23",{"name":39,"class":40},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":357,"minAge":18,"maxAge":358,"enrollmentInfo":359,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":365,"leadSponsor":366,"locationsCount":41},"100613561","impact-of-liver-transplantation-on-sexual-life-and-function-100613561","NCT07268196","Impact of Liver Transplantation on Sexual Life and Function","Inclusion Criteria:\n\n1. Married male Patients.\n2. Decompensated Chronic Liver Disease awaiting elective liver transplantation.\n3. Post Liver Transplant patients with stable graft function.\n\nExclusion Criteria:\n\n1. Negative consent.\n2. Patients with ongoing medical and surgical issues (biliary complications, graft complication etc.).\n3. Acute on Chronic Liver Failure and Acute Liver Failure patients.","MALE","60 Years",{"count":163,"type":22},"Liver Transplantation (LT) is a lifesaving intervention with around 90% of recipients currently surviving the first postoperative year and subsequent life expectancy now exceeding 20 years. After the post-operative recovery period, however, LT recipients become more and more confronted with the challenges of re-engagement with life after transplantation, a need to reach a new stability, reestablish function in everyday life, reconnect with valued roles, regain independence, and resume work Sexual function is a very important parameter in the evaluation of Quality of Life (QoL), as it has been shown that sexual dysfunction in transplant patients is associated with increased depression and decreased QoL. There are several studies in the relevant literature supporting the recovery of sexual function in patients after liver transplantation. It has been found that recovery was observed in erectile dysfunction in male patients 6 months after liver transplantation.",[362],"Chronic Liver Disease and Cirrhosis",{"date":285,"type":33},{"date":347,"type":33},{"date":349,"type":22},{"name":39,"class":40},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":41},"100585962","the-study-of-association-of-helicobacter-infections-in-biliary-tract-cancers-100585962","NCT06909188","The Study of Association of Helicobacter Infections in Biliary Tract Cancers","Inclusion Criteria:\n\n* Biliary tract carcinoma patients who underwent resection\n* Patients undergoing cholecystectomy for benign biliary disease.\n* Voluntary healthy liver donors with no gallbladder pathology\n* Patients undergoing cholecystectomy for conditions with high risk of malignancy\n\nExclusion Criteria:\n\n* Patients who have taken H.pylori eradication previously in last three months.",{"count":374,"type":22},250,"Biliary tract carcinoma (BTC) includes gallbladder carcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma, intrahepatic cholangiocarcinoma. Chronic infections of the biliary tract are major drivers of cancer. Helicobacter species is one of the most established pro-oncogenic pathogens for gastric malignancy.\n\nIn addition to H Pylori, H.bilis and H.hepaticus have a significantly higher incidence in bile from biliary tract and gallbladder cancer patients than in patients with gallstones\u002Fcholecystitis.\n\nThis, together with the high prevalence of gallstones, makes it important to evaluate the role of Helicobacter in biliary tract cancers. This study aims to compare the prevalence of Helicobacter sp.(pylori, bilis, hepaticus). This study will include biliary tract carcinoma patients, benign biliary disease patients, high risk conditions for malignancy and Voluntary healthy liver donors with no gallbladder pathology. HPE samples will be assessed and association of Helicobacter sp will be studied among all 4 arms.\n\nAll the included samples will be assessed for Helicobacter species using giemsa stain and DNA PCR. Results will be studied to compare the prevalence of Helicobacter sp. in Biliary tract malignancy and benign biliary diseases.",[377],"Biliary Tract Cancer","2025-12-05",{"date":327,"type":33},{"date":381,"type":33},"2025-03-31",{"date":383,"type":22},"2026-05-31",{"name":39,"class":40},{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":391,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":400,"locationsCount":41},"100613762","to-study-the-clinical-course-and-outcomes-of-non-electively-hospitalised-patients-of-chronic-liver-disease-cld-with-hepatic-or-extra-hepatic-predominant-organ-failures-at-6-months-100613762","NCT07270809","To Study the Clinical Course and Outcomes of Non-electively Hospitalised Patients of Chronic Liver Disease (CLD) With Hepatic or Extra-hepatic Predominant Organ Failure(s) at 6 Months.","Inclusion Criteria:\n\n1. Age 18-70 years\n2. CLD with or without cirrhosis with 1st or subsequent admissions for decompenasation and irrespective of any prior decompensation\n3. Non-electively hospitalized\n\nExclusion Criteria:\n\n1. HCC\n2. NCPF\u002FEHPVO\n3. Pregnancy\n4. Post-Liver transplant",{"count":163,"type":22},"Title - To study the clinical course and outcomes of non-electively hospitalised patients of chronic liver disease (CLD) with Hepatic or Extra-hepatic predominant organ failure(s) at 6 months.\n\nSummary - ACLF is a condition where acute insult leading to worsening liver failure with or without extra-hepatic failure leads to a high short-term mortality. However, the presence of cirrhosis, prior decompensation, non-hepatic\u002Fsystemic acute insult, organ failure and treatment are different in different part of the world. This is due to in-homogenous patient cohort. The current study was planned for all patients of CLD, who were non-electively hospitalized and were followed up for long-term to identify the differences in clinical course, acute insult, organ failure, therapy and outcome in relation to liver failure with or without extra-hepatic organic failure. In the study the laboratory, clinical parameters, inflammatory and regenerative markers will be evaluated as a marker of disease progression, reversal, recompensation or regression. This will enable us to differentiate the ACLF between east and west, guide us for defining the natural course of CLD with failure.",[28],"2025-11-26",{"date":396,"type":33},"2025-12-08",{"date":398,"type":22},"2025-11-30",{"date":291,"type":22},{"name":39,"class":40},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":408,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":425,"locationsCount":41},"100555673","high-volume-versus-standard-volume-plasma-exchange-in-patients-with-acute-liver-failure-with-cerebral-edema-100555673","NCT06515145","High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema","To Evaluate the Safety and Efficacy of High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema -A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\nPatients with acute liver failure defined as patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease.\n\nCerebral edema documented on CT-scan and arterial ammonia \\>150 ug\u002FdL\n\nExclusion Criteria:\n\n1. Age \\\u003C18 or \\> 70 years\n2. HCC\n3. Active untreated Sepsis\u002FDIC\n4. Hemodynamic instability non-responsive to initial fluid resuscitation with norepinephrine \\>0.1 ug\u002Fkg\u002Fmin\n5. Post-resection and malignancy related liver failure\n6. Coma of non-hepatic origin\n7. Patients with uncontrolled infection\n8. Patients with pulmonary involvement with Pa02\u002FFio2 ratio below 200.\n9. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis\n10. Extremely moribund patients with an expected life expectancy of less than 24 hours\n11. Pregnancy related liver failure\n12. Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \\>3, or oxygen\u002Fsteroid-dependent chronic obstructive pulmonary disease)\n13. Refusal to participate in the study\n14. Drug-induced ALF",{"count":72,"type":22},[25],"In this prospective randomized controlled trial Investigator aim to evaluate the impact of high versus standard volume plasma-exchange in patients with acute liver failure with cerebral edema and clinical outcomes. ALF who meet the inclusion and exclusion criteria within the first 12 hours will be randomized into two groups\n\nInterventional - High-volume plasma exchange Active Comparator - Standard volume plasma exchange\n\nExpected outcome of the project-.\n\n1. Primary end points: Time to improvement in cerebral edema\n2. Secondary end points:\n\nTo study the adverse events of therapy (volume overload, pulmonary complications, allergic reactions) etc.\n\nTransplant-free survival at day 21",[284,412],"Cerebral Edema",[414,415,416,417,418],"Plasma-exchange","systemic inflammatory response syndrome","lactate","CRRT","sepsis","2025-09-18",{"date":421,"type":33},"2025-09-19",{"date":423,"type":22},"2025-12-01",{"date":209,"type":22},{"name":39,"class":40},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":434,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":439,"conditions":440,"keywords":442,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":4},"100603055","phase-1-national-collaborative-centre-for-hepatic-regenerative-medicine-nc-chrm-phase-i-study-on-safety-and-efficacy-of-mesenchymal-stem-cell-msc-therapy-in-non-viral-acute-on-chronic-liver-failure-aclf-100603055","NCT07131540","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Phase I Study on Safety and Efficacy of Mesenchymal Stem-Cell (MSC) Therapy in Non-Viral Acute-on-Chronic Liver Failure (ACLF)","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): To Study the Safety and Efficacy of Mesenchymal Stem-Cell Therapy in the Management of Non-viral ACLF Patients: Phase-I Clinical Study","NC-CHRM","Inclusion Criteria:\n\n* ACLF patients with Model for End-Stage Liver Disease (MELD) \\>18 or APASL ACLF Research Consortium (AARC) grade 2 or more with (no or single extrahepatic organ dysfunction or failure having no option of liver transplant).\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>65 yrs\n* Patients with active sepsis\n* Patients with hepatic venous outflow tract obstruction (HVOTO) or Extrahepatic portal vein obstruction (EHPVO)\n* Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy\n* Active bleed (mucosal or variceal) or severe coagulopathy (platelets \\\u003C20,000 or INR\\>4)\n* Patients with refractory shock requiring norepinephrine \\>0.5ug\u002Fkg\u002Fmin\n* Patients with severe Acute Respiratory Distress Syndrome (ARDS) with Pa02\u002FFi02 \\\u003C150\n* Patients with retroviral infections\n* Autoimmune hepatitis\n* Viral etiology of liver disease\n* Co-existent Hepatitis B, Hepatitis C, HIV\n* Chronic kidney disease\n* Multiorgan failure or disseminated intravascular coagulation (DIC)\n* Patients improving on standard medical treatment\n* Patients on immunosuppressive medications\n* Pregnancy or active breastfeeding\n* Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease)\n* Lack of informed consent","65 Years",{"count":436,"type":22},10,[438],"PHASE1","Liver disease deaths are rising, but transplants remain scarce in India. With over 100,000 needed annually and only \\~2,500 performed, non-transplant options are urgently needed. Regenerative therapy, especially MSCs, shows promise but lacks validation, particularly for non-viral Acute on Chronic Liver Failure (ACLF). The proposed NC-CHRM aims to develop and validate MSC-based therapy to promote native liver regeneration and offer a safe, effective, transplant-free treatment.",[441],"Acute-On-Chronic Liver Failure",[146,443,444],"MSC","Liver failure","2025-08-21",{"date":447,"type":33},"2025-08-28",{"date":449,"type":22},"2026-01",{"date":451,"type":22},"2031-12",{"name":39,"class":40},{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":432,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":434,"enrollmentInfo":460,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":475,"locationsCount":41},"100603035","national-collaborative-centre-for-hepatic-regenerative-medicine-nc-chrm-single-vs-repeated-cycle-of-granulocyte-colony-stimulating-factor-gcsf--darbepoetin-in-early-decompensated-cirrhosis-100603035","NCT07131280","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Single vs Repeated Cycle of Granulocyte Colony-Stimulating Factor (GCSF) & Darbepoetin in Early Decompensated Cirrhosis","National Collaborative Centre for Hepatic Regenerative Medicine(NC-CHRM): To Study the Efficacy of Single vs Repeated Cycle of GCSF+ Darbepoetin in Long Term Transplant Free Management of Patient With Early Decompensated Cirrhosis","Inclusion Criteria:\n\n* Early decompensated cirrhosis patients with MELD \\\u003C16\n\nExclusion Criteria:\n\n* Patients with age less than 18 years or more than 65 years\n* Patients with Grade III ascites\n* CHILD C cirrhosis\n* Patients with a known focus of sepsis; spontaneous Bacterial Peritonitis (SBP)\n* variceal bleeding in past 3months\n* Hepatocellular Carcinoma (HCC) or other malignancy\n* Acute Kidney Injury (AKI) with serum Creatinine \\>1.5 mg\u002F dl, multi-organ failure, grade 3 or 4 Hepatic Encephalopathy (HE),\n* HIV seropositivity\n* Medically uncontrolled essential hypertension\n* Pregnancy\n* Viral etiology of liver disease\n* Co-existent Hepatitis B, Hepatitis C, HIV\n* Chronic kidney disease\n* Lack of informed consent",{"count":117,"type":22},[25],"Chronic liver disease is a growing health concern, with limited access to liver transplants. This study addresses the urgent need for alternatives by exploring regenerative therapies, like G-CSF, to boost the liver's natural repair. The goal is to develop safe, effective, and accessible treatments for patients who cannot undergo transplant.",[464],"Decompensated Cirrhosis",[466,467,468],"GCSF","Decompensated cirrhosis","Darbepoetin","2025-08-19",{"date":471,"type":33},"2025-08-20",{"date":473,"type":22},"2025-09",{"date":451,"type":22},{"name":39,"class":40},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":432,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":434,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":486,"conditions":487,"keywords":488,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":41},"100603037","phase-2-national-collaborative-centre-for-hepatic-regenerative-medicine-nc-chrm-evaluating-mesenchymal-stem-cell-therapy-in-non-viral-acute-on-chronic-liver-failure-aclf-patient--phase-ii-trial-100603037","NCT07131306","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem Cell Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patient- Phase-II Trial","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): To Study the Safety and Efficacy of Mesenchymal Stem-Cell (MSC) Therapy in the Management of Non-viral ACLF Patients: Phase-II Clinical Study","Inclusion Criteria:\n\n* ACLF patients with Model for End-Stage Liver Disease(MELD)\\>18 or APASL ACLF Research Consortium(AARC) grade 2 or more with (no or single extrahepatic organ dysfunction or failure having no option of liver transplant).\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>65 yrs\n* Patients with active sepsis\n* Patients with hepatic venous outflow tract obstruction (HVOTO) or Extrahepatic portal vein obstruction (EHPVO)\n* Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy\n* Active bleed (mucosal or variceal) or severe coagulopathy (platelets \\\u003C20,000 or INR\\>4)\n* Patients with refractory shock requiring norepinephrine \\>0.5ug\u002Fkg\u002Fmin\n* Patients with severe Acute Respiratory Distress Syndrome (ARDS) with Pa02\u002FFi02 \\\u003C150\n* Patients with retroviral infections\n* Autoimmune hepatitis\n* Viral etiology of liver disease\n* Co-existent Hepatitis B, Hepatitis C, HIV\n* Chronic kidney disease\n* Multiorgan failure or Disseminated Intravascular Coagulation (DIC)\n* Patients improving on standard medical treatment\n* Patients on immunosuppressive medications\n* Pregnancy or active breastfeeding\n* Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease)\n* Lack of informed consent",{"count":163,"type":22},[485],"PHASE2","Liver disease deaths are rising, but transplants remain scarce in India. With over 100,000 needed annually and only \\~2,500 performed, non-transplant options are urgently needed. Regenerative therapy, especially MSCs, shows promise but lacks validation, particularly for non-viral ACLF. The proposed NC-CHRM aims to develop and validate MSC-based therapy to promote native liver regeneration and offer a safe, effective, transplant-free treatment.",[441],[243,489,146,490],"Mesenchymal Stem Cells","Liver Regeneration",{"date":471,"type":33},{"date":493,"type":22},"2027-01",{"date":495,"type":22},"2031-08",{"name":39,"class":40},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":505,"briefSummary":506,"conditions":507,"keywords":510,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":41},"100603144","the-efficacy-of-intravenous-amino-acids-in-reducing-the-occurrence-of-aki-after-live-donor-liver-transplant-100603144","NCT07132697","The Efficacy of Intravenous Amino Acids in Reducing the Occurrence of AKI After Live Donor Liver Transplant","The Efficacy of Intravenous Amino Acids in Reducing the Occurrence of AKI After Live Donor Liver Transplant: An Open Label Randomized Trial","Inclusion Criteria\n\n1. All LDLT Recipient\n2. Age: \\> 18 years\n3. Signed informed consent\n\nExclusion Criteria\n\n1. Negative consent.\n2. Pediatric LDLT.\n3. ALF patient undergoing LDLT.\n4. Patients on intermittent or continuous renal replacement therapy.\n5. Patients with eGFR less then 40 ml per min per 1.73 m2.\n6. SLKT and prior Kidney transplant.\n7. Patient has a hypersensitivity (known allergy) to one or more of the included amino acids.\n8. Patient has a known congenital alteration of amino acid metabolism.",{"count":163,"type":22},[25],"This prospective, open-label, randomized controlled trial aims to evaluate the efficacy of intravenous amino acid infusion in reducing AKI after LDLT. Eligible adult patients undergoing LDLT will be randomized into two groups: one receiving Continuous infusion of a L-amino acids mixture in a dose of 2 g\u002Fkg dry body weight\u002Fday (to a maximum 100 g\u002Fday) after induction of anesthesia and insertion of CVP line till 72 hours after treatment initiation, and the other receiving standard management. The primary outcome is the incidence of AKI as per KDIGO criteria within 7 days of transplant.",[508,509],"Liver Transplant; Complications","AKI - Acute Kidney Injury",[511],"Liver Transplantation, Acute Kidney Injury, Amino Acids, KDIGO, NGAL, Randomized Controlled Trial","2025-08-13",{"date":471,"type":33},{"date":515,"type":22},"2025-08-25",{"date":517,"type":22},"2026-09-01",{"name":39,"class":40},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":432,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":434,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":527,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":540,"locationsCount":541},"100598732","phase-3-national-collaborative-centre-for-hepatic-regenerative-medicine-nc-chrm-evaluating-mesenchymal-stem-cell-msc-therapy-in-non-viral-acute-on-chronic-liver-failure-aclf-patients---phase-iii-trial-100598732","NCT07075315","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem-Cell (MSC) Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patients - Phase-III Trial","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): To Study the Safety and Efficacy of Mesenchymal Stem-Cell Therapy in the Management of Non-viral ACLF Patients: Phase-III Clinical Study","Inclusion Criteria:\n\n* ACLF patients with Model for End-Stage Liver Disease (MELD) score \\>18 or APASL ACLF Research Consortium (AARC) grade 2 or more with (no or single extrahepatic organ dysfunction or failure having no option of liver transplant.\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>65 yrs\n* Patients with active sepsis\n* Patients with Hepatic Venous Outflow Tract Obstruction(HVOTO) or Extrahepatic Portal Vein Obstruction (EHPVO)\n* Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy\n* Active bleed (mucosal or variceal) or severe coagulopathy (platelets \\\u003C20,000 or INR\\>4)\n* Patients with refractory shock requiring norepinephrine \\>0.5ug\u002Fkg\u002Fmin\n* Patients with severe Acute Respiratory Distress Syndrome (ARDS) with Pa02\u002FFi02 \\\u003C150\n* Patients with retroviral infections\n* Autoimmune hepatitis\n* Viral etiology of liver disease\n* Co-existent Hepatitis B, Hepatitis C, HIV\n* Chronic kidney disease\n* Multiorgan failure or Disseminated Intravascular Coagulation\n* Pregnancy or active breastfeeding\n* Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease)\n* Lack of informed consent",{"count":163,"type":22},[528],"PHASE3","Liver disease deaths are rising, but transplants remain scarce in India. With over 100,000 needed annually and only \\~2,500 performed, non-transplant options are urgently needed. Regenerative therapy, especially mesenchymal stem cells (MSCs), shows promise but lacks validation, particularly for non-viral ACLF. The proposed NC-CHRM aims to develop and validate MSC-based therapy to promote native liver regeneration and offer a safe, effective, transplant-free treatment.",[441],[532,146,533,432],"Acute on chronic Liver Failure","Mesenchymal Stem Cell","2025-08-12",{"date":536,"type":33},"2025-08-17",{"date":538,"type":22},"2028-01",{"date":451,"type":22},{"name":39,"class":40},3,""]