[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593160":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":44,"centralContacts":49,"locations":57,"responsibleParty":74,"collaborators":31,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":31,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":31,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":31,"overallStatus":60,"whyStopped":31,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,15,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Medical treatment","ACTIVE_COMPARATOR","Standard medical therapy including lactulose, bowel enema and albumin will be continued in both groups.",[13,14],"Drug: Lactulose","Biological: Albumin",{"label":16,"type":17,"description":18,"interventionNames":19},"Single cycle of G-CSF + darbepoetin and standard medical treatment","EXPERIMENTAL","* G-CSF will be given at a dose of 5 µg\u002Fkg s\u002Fc at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30.\n* Darbepoetin will be given s\u002Fc at dose of 40 mcg once a week (total 4 doses) for 1 month.\n* Standard medical therapy including lactulose, bowel enema and albumin will be continued in both groups.",[20,21,13,14],"Drug: Darbepoetin","Drug: G-CSF",{"label":23,"type":17,"description":18,"interventionNames":24},"Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)",[20,21,13,14],[26,32,36,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Darbepoetin","Darbepoetin will be given s\u002Fc at dose of 40 mcg once a week (total 4 doses) for 1 month",[16,23],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"G-CSF","G-CSF will be given at a dose of 5 µg\u002Fkg s\u002Fc at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30",[16,23],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Lactulose","Standard Medical Tretament part",[16,9,23],{"type":41,"name":42,"description":38,"armGroupLabels":43,"otherNames":31},"BIOLOGICAL","Albumin",[16,9,23],[45],{"name":46,"affiliation":47,"role":48},"Dr Manoj Kumar Sharma, DM","Institute of Liver and Biliary Sciences","STUDY_DIRECTOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},"Dr Shreya Singh, MD","CONTACT","01146300000","shreyasingh2746@gmail.com",{"name":46,"role":52,"phone":53,"phoneExt":31,"email":56},"manojkumardm@gmail.com",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Institute of Liver & Biliary Sciences (ILBS)","RECRUITING","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":67,"coordinates":68},"Point",[69,70],77.2148,28.62137,{"lat":70,"lon":69},[73],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},{"type":75,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","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",false,"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","ALL","18 Years","70 Years",{"count":87,"type":88},60,"ESTIMATED","INTERVENTIONAL",[91],"NA","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 .",[94],"Decompensated Liver Cirrhosis","2026-05-19",{"date":97,"type":98},"2026-05-22","ACTUAL",{"date":100,"type":98},"2025-06-04",{"date":102,"type":88},"2026-12-30",{"name":5,"class":6},1]