Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT07002827
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D007792', 'term': 'Lactulose'}, {'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2025-05-03', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in innate immunity between the groups.', 'timeFrame': '6 months', 'description': 'Innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants developed new-onset of LRE (such as ascites, HE, AKI, bleed and sepsis) or show mortality in all the groups.', 'timeFrame': '6 months'}, {'measure': 'Cumulative incidence of second decompensation in all the groups.', 'timeFrame': '6 months & 1 year'}, {'measure': 'Transplant-free survival.', 'timeFrame': '6 months & 1 year'}, {'measure': 'Number of participants with improvement in liver disease severity indices (CTP).', 'timeFrame': '6 months'}, {'measure': 'Number of participants with improvement in liver disease severity indices (MELD).', 'timeFrame': '6 months'}, {'measure': 'Number of participants with change in adaptive immunity(T-cell, B-cell and NK cells distribution only )', 'timeFrame': '6 months'}, {'measure': 'Number of participants with change in inflammation (a panel of pro and anti-inflammatory cytokines).', 'timeFrame': '6 months'}, {'measure': 'Change in gcsf levels and EPO levels at baseline and completion of each cycle.', 'timeFrame': '6 months'}, {'measure': 'Proportion of participants completing treatment without major adverse effects;', 'timeFrame': '6 months'}, {'measure': 'Number of participants with change in peripheral blood CD34+ Hematopoietic Stem Cells count at 6months.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Decompensated Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': '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 .', 'detailedDescription': 'Aim: To study the efficacy of single vs repeated cycle of Granulocyte Colony Stimulating Factor+ darbopoetin vs standard medical treatmenton immunometabolic profile in patient with early decompensated cirrhosis\n\nStudy population:\n\n* Age 18-70 years\n* Early decompensated cirrhosis MELD \\< 16 , CTP \\< 9B\n* Uncomplicated ascites\n* A Prospective Randomized Controlled Trial.\n* Single Centre.\n* Open label.\n* Block Randomization will be done , it will be implemented by IWRS method.\n* The study will be conducted in Department of Hepatology, ILBS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-70 years\n2. Decompensated cirrhosis patients\n3. Uncomplicated ascites,\n4. CTP ≤ 9B and MELD \\<16\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/active alcohol abuse last intake ≤ 3 months\n5. Suspected autoimmune hepatitis (ANA/ASMA-positive in titers 1:80 and/ or IgG 1.5 times upper limit of normal),\n6. Hemolytic anaemia -Sickle cell disease or thalassemia\n7. Patients with Grade III ascites /complicated 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/o Seizures\n12. Hepatocellular Carcinoma (HCC) or other malignancy\n13. Acute Kidney Injury (AKI) with serum Creatinine \\>1.5 mg/ 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 /Stroke\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 \\< 0.4'}, 'identificationModule': {'nctId': 'NCT07002827', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'ILBS-Cirrhosis-73'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Medical treatment', 'description': 'Standard medical therapy including lactulose, bowel enema and albumin will be continued in both groups.', 'interventionNames': ['Drug: Lactulose', 'Biological: Albumin']}, {'type': 'EXPERIMENTAL', 'label': 'Single cycle of G-CSF + darbepoetin and standard medical treatment', 'description': '* G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30.\n* Darbepoetin will be given s/c 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.', 'interventionNames': ['Drug: Darbepoetin', 'Drug: G-CSF', 'Drug: Lactulose', 'Biological: Albumin']}, {'type': 'EXPERIMENTAL', 'label': 'Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)', 'description': '* G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30.\n* Darbepoetin will be given s/c 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.', 'interventionNames': ['Drug: Darbepoetin', 'Drug: G-CSF', 'Drug: Lactulose', 'Biological: Albumin']}], 'interventions': [{'name': 'Darbepoetin', 'type': 'DRUG', 'description': 'Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month', 'armGroupLabels': ['Single cycle of G-CSF + darbepoetin and standard medical treatment', 'Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)']}, {'name': 'G-CSF', 'type': 'DRUG', 'description': 'G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30', 'armGroupLabels': ['Single cycle of G-CSF + darbepoetin and standard medical treatment', 'Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)']}, {'name': 'Lactulose', 'type': 'DRUG', 'description': 'Standard Medical Tretament part', 'armGroupLabels': ['Single cycle of G-CSF + darbepoetin and standard medical treatment', 'Standard Medical treatment', 'Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)']}, {'name': 'Albumin', 'type': 'BIOLOGICAL', 'description': 'Standard Medical Tretament part', 'armGroupLabels': ['Single cycle of G-CSF + darbepoetin and standard medical treatment', 'Standard Medical treatment', 'Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'contacts': [{'name': 'Dr Shreya Singh, MD', 'role': 'CONTACT', 'email': 'shreyasingh2746@gmail.com', 'phone': '01146300000'}], 'facility': 'Institute of Liver & Biliary Sciences (ILBS)', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Dr Shreya Singh, MD', 'role': 'CONTACT', 'email': 'shreyasingh2746@gmail.com', 'phone': '01146300000'}, {'name': 'Dr Manoj Kumar Sharma, DM', 'role': 'CONTACT', 'email': 'manojkumardm@gmail.com', 'phone': '01146300000'}], 'overallOfficials': [{'name': 'Dr Manoj Kumar Sharma, DM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Liver and Biliary Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}