Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-28 @ 5:47 AM
Study NCT ID:
NCT02642003
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2015-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-15', 'studyFirstSubmitDate': '2015-12-21', 'studyFirstSubmitQcDate': '2015-12-29', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants alive at 6 months', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '27930386', 'type': 'DERIVED', 'citation': 'Prajapati R, Arora A, Sharma P, Bansal N, Singla V, Kumar A. Granulocyte colony-stimulating factor improves survival of patients with decompensated cirrhosis: a randomized-controlled trial. Eur J Gastroenterol Hepatol. 2017 Apr;29(4):448-455. doi: 10.1097/MEG.0000000000000801.'}]}, 'descriptionModule': {'briefSummary': 'Background and Aims: Liver transplantation is the only curative treatment modality for decompensated cirrhosis and is limited by donor organ availability and financial resources; thus many patients die while awaiting liver transplant. Granulocyte colony stimulating factor (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been shown to benefit patients with liver disease. The investigators evaluated the efficacy of GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial.\n\nPatients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At the end of 6 months their survival were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years to75 years\n* Patients of decompensated cirrhosis with CTP ≥6 and ≤ 13\n* Liver transplantation not feasible soon (due to financial reasons or unavailability of donors).\n\nExclusion Criteria:\n\n* Hepatocellular Carcinoma\n* Sepsis (Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP): Patients were included after sepsis is controlled.\n* Any organ failure\n* Grade 3 or 4 Hepatic Encephalopathy, Active Variceal bleed, Hepatorenal Syndrome: Patients might be included after clinical improvement\n* HIV seropositivity\n* Pregnancy\n* Refusal to participate in the study\n* Previous known hypersensitivity to G-CSF'}, 'identificationModule': {'nctId': 'NCT02642003', 'briefTitle': 'To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Sir Ganga Ram Hospital'}, 'officialTitle': 'To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis', 'orgStudyIdInfo': {'id': 'Gastro-2014-OL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GCSF+SMT', 'description': '5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months', 'interventionNames': ['Drug: Granulocyte Colony Stimulating Factor']}, {'type': 'NO_INTERVENTION', 'label': 'SMT'}], 'interventions': [{'name': 'Granulocyte Colony Stimulating Factor', 'type': 'DRUG', 'armGroupLabels': ['GCSF+SMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110060', 'city': 'New Delhi', 'state': 'New Delhi', 'country': 'India', 'facility': 'Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Ganga Ram Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co investigator', 'investigatorFullName': 'Dr. Ashish Kumar', 'investigatorAffiliation': 'Sir Ganga Ram Hospital'}}}}