Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT01036932
Status:
UNKNOWN
Last Update Posted:
2009-12-21
First Post:
2009-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Granulocyte Colony Stimulating Factor(G-CSF) Therapy for Patients With ACLF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}], 'ancestors': [{'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-18', 'studyFirstSubmitDate': '2009-12-17', 'studyFirstSubmitQcDate': '2009-12-18', 'lastUpdatePostDateStruct': {'date': '2009-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mobilization of CD34 cells in the peripheral blood', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'clinical/ biochemical improvement in liver function profile', 'timeFrame': '2 months'}, {'measure': 'frequency of multi-organ failure', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute on Chronic Liver Failure']}, 'referencesModule': {'references': [{'pmid': '22119930', 'type': 'DERIVED', 'citation': 'Garg V, Garg H, Khan A, Trehanpati N, Kumar A, Sharma BC, Sakhuja P, Sarin SK. Granulocyte colony-stimulating factor mobilizes CD34(+) cells and improves survival of patients with acute-on-chronic liver failure. Gastroenterology. 2012 Mar;142(3):505-512.e1. doi: 10.1053/j.gastro.2011.11.027. Epub 2011 Nov 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether Granulocyte Colony Stimulating factor(G-CSF) therapy is effective in the treatment of patients with Acute on chronic liver failure(ACLF). The investigators hypothesize that ACLF is a disease where severe hepatic impairment is accompanied by impaired hepatic regeneration. BMC mobilization using G-CSF therapy, or G-CSF therapy per se would increase the regenerative capacity of the liver and shall lead to clinical, biochemical and histological improvements in patients with ACLF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease.(APASL criteria)\n\nExclusion Criteria:\n\n* HCC or portal vein thrombosis. Refusal to participate in the study. Sepsis ( Any culture positive: blood, urine, focus of infection on Xray chest, any other obvious source of infection: UTI, SBP) Multi organ failure. Grade 3 or 4 hepatic encephalopathy.'}, 'identificationModule': {'nctId': 'NCT01036932', 'briefTitle': 'Granulocyte Colony Stimulating Factor(G-CSF) Therapy for Patients With ACLF', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Govind Ballabh Pant Hospital'}, 'officialTitle': 'To Study the Safety and Efficacy of G-CSF Therapy on the CD 34 Cell Mobilization and Outcome of Patients With ACLF', 'orgStudyIdInfo': {'id': 'IEC MAMC 179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'G-CSF group', 'description': 'Patients with Acute on chronic liver failure after baseline investigations for the etiology of the acute event and the underlying chronic disease were given Granulocyte Colony Stimulating Factor therapy for a total duration of one month.', 'interventionNames': ['Drug: Granulocyte Colony Stimulating Factor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'After baseline characterization and work up for underlying acute and chronic liver disease, patients were given placebo along with the standard therapy', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Granulocyte Colony Stimulating Factor', 'type': 'DRUG', 'description': 'Dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.', 'armGroupLabels': ['G-CSF group']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'dose of 1ml s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110002', 'city': 'New Delhi', 'state': 'New Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Shiv K Sarin, MD, DM', 'role': 'CONTACT', 'email': 'shivsarin@gmail.com', 'phone': '91-11-23234242', 'phoneExt': '5201'}, {'name': 'Shiv K Sarin, MD, DM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shiv K Sarin', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Shiv K Sarin, MD, DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'G B Pant Hospital, New Delhi, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Govind Ballabh Pant Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr S.K.Sarin', 'oldOrganization': 'Head, Gastroenterology'}}}}