Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-27 @ 8:10 AM
Study NCT ID:
NCT01341951
Status:
UNKNOWN
Last Update Posted:
2011-04-26
First Post:
2011-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017114', 'term': 'Liver Failure, Acute'}], 'ancestors': [{'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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-25', 'studyFirstSubmitDate': '2011-04-15', 'studyFirstSubmitQcDate': '2011-04-25', 'lastUpdatePostDateStruct': {'date': '2011-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'clinical and biochemical improvement in liver functions', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver failure, Acute'], 'conditions': ['Liver Failure, Acute']}, 'referencesModule': {'references': [{'pmid': '18537187', 'type': 'BACKGROUND', 'citation': 'Spahr L, Lambert JF, Rubbia-Brandt L, Chalandon Y, Frossard JL, Giostra E, Hadengue A. Granulocyte-colony stimulating factor induces proliferation of hepatic progenitors in alcoholic steatohepatitis: a randomized trial. Hepatology. 2008 Jul;48(1):221-9. doi: 10.1002/hep.22317.'}]}, 'descriptionModule': {'briefSummary': 'Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis', 'detailedDescription': 'In this study 4 groups have been taken. Two groups of cases including Alcoholic patients and acute liver failure which are given G-CSF therapy and two groups of controls given standard therapy. Primary end point is to see the mobilization of CD-34 hematopoietic cells and survival. Secondary end point is to see the clinical and biochemical improvement in liver functions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Acute Liver failure as defined by AASLD.65\n* Patients with Alcoholic hepatitis defined as follows: decades of heavy alcohol use (mean intake, approximately 100 g per day).The combination of an aspartate aminotransferase level that is elevated (but \\<300 IU per milliliter) and a ratio of the aspartate aminotransferase level to the alanine aminotransferase level that is more than 2, a total serum bilirubin level of more than 5 mg per deciliter (86 μmol per liter), an elevated INR, and neutrophilia.\n\nExclusion Criteria:\n\n• Known hypersensitivity to filgrastim\n\n* creatinine \\> 150 µmol/L\n* infection or hemorrhage within the last 10 days\n* documented hepatocellular carcinoma\n* hepatitis B,C or human immunodeficiency virus seropositivity and pregnancy'}, 'identificationModule': {'nctId': 'NCT01341951', 'acronym': 'G-CSF', 'briefTitle': 'Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis', 'organization': {'class': 'UNKNOWN', 'fullName': 'PIMERIndia'}, 'officialTitle': 'G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study', 'orgStudyIdInfo': {'id': 'PIMERIndia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G-CSF therapy in acute liver failure and alcoholic hepatitis', 'description': 'G-CSF therapy given in cases with acute liver failure and alcoholic hepatitis', 'interventionNames': ['Drug: Granulocyte colony stimulating factor']}], 'interventions': [{'name': 'Granulocyte colony stimulating factor', 'type': 'DRUG', 'description': '300 I.U twice daily for 5 days', 'armGroupLabels': ['G-CSF therapy in acute liver failure and alcoholic hepatitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1600012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Arun Sharma, DM', 'role': 'CONTACT', 'email': 'drarunvashisht@yahoo.co.in', 'phone': '08872721666'}, {'name': 'Arun Sharma, DM Hepatology', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Postgraduate Institute of Medical Education & Research Chandigarh India', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'centralContacts': [{'name': 'Arun Sharma, DM', 'role': 'CONTACT', 'email': 'drarunvashisht@yahoo.co.in', 'phone': '08872721666'}, {'name': 'Virendra Singh', 'role': 'CONTACT', 'email': 'virendrasingh100@hotmail.com', 'phone': '09914209338'}], 'overallOfficials': [{'name': 'virendra singh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Postgraduate Institute of Medical Education and Research Chandigarh India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Virendra Singh', 'oldOrganization': 'Postgraduate Institute of Medical Education and Research, Chandigarh, India'}}}}