Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-31 @ 5:41 PM
Study NCT ID:
NCT01112033
Status:
COMPLETED
Last Update Posted:
2015-08-07
First Post:
2010-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biliverdin Reductase A in Chronic Hepatitis C Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'peripheral blood, liver biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-05', 'studyFirstSubmitDate': '2010-04-23', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess differences in BLVRA expression in the liver and PBMC in HCV infected patients in responders and non-responders to standard antiviral therapy.', 'timeFrame': '72 weeks'}], 'secondaryOutcomes': [{'measure': 'To analyze the association of genetic polymorphisms of BLVRA with disease progression and treatment response in HCV infected patients.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['biliverdin reductase', 'BLVRA', 'hepatitis C', 'HCV', 'peripheral blood mononuclear cells', 'PBMC', 'liver', 'genetic polymorphisms'], 'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '23536765', 'type': 'RESULT', 'citation': 'Subhanova I, Muchova L, Lenicek M, Vreman HJ, Luksan O, Kubickova K, Kreidlova M, Zima T, Vitek L, Urbanek P. Expression of Biliverdin Reductase A in peripheral blood leukocytes is associated with treatment response in HCV-infected patients. PLoS One. 2013;8(3):e57555. doi: 10.1371/journal.pone.0057555. Epub 2013 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'In this project, the investigators aim to study the role of biliverdin reductase A (BLVRA) in HCV infected patients prior and during/after standard antiviral therapy in association with viral clearance, disease progression and treatment response and in comparison with healthy subjects.', 'detailedDescription': '1. To analyze biliverdin reductase (BLVRA) expression in the liver of HVC infected patients undergoing liver biopsy followed by standard antiviral treatment (peg-interferon plus ribavirin combination therapy) and patients with other forms of liver diseases undergoing liver biopsy as controls.\n2. To analyze BLVRA expression in peripheral blood leukocytes (PBL) of therapeutically naïve HCV patients, during/after standard antiviral therapy and healthy controls.\n3. To analyze BVLRA genetic polymorphisms both in HCV infected patients and healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Estimated enrollment: BLVRA expression study: 50 - 100 HCV patients 50 healthy volunteers Polymorphisms of BLVRA study: 300 HCV patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBLVRA expression study\n\n* Therapeutically naïve HCV patients undergoing antiviral treatment with peg-interferon plus ribavirin combination therapy\n\nBLVRA genetic polymorphisms study\n\n* HCV infected patients prior, during, after or without antiviral therapy\n\nExclusion Criteria:\n\n* Co-infection with HAV, HBV and HIV\n* Disorders of heme metabolism'}, 'identificationModule': {'nctId': 'NCT01112033', 'briefTitle': 'Biliverdin Reductase A in Chronic Hepatitis C Virus Infection', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Biliverdin Reductase A in Chronic Hepatitis C Virus Infection', 'orgStudyIdInfo': {'id': 'BLVRA1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic HCV infection', 'description': 'The study was performed on therapeutically naïve patients with chronic HCV infection. Patients with positivity of anti-HCV antibodies, and detectable HCV RNA in serum for at least 6 months, were included in the study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '128 60', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Institute of Clinical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University in Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Iva Subhanova', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University, Czech Republic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Military University Hospital, Prague', 'class': 'OTHER'}, {'name': 'General University Hospital, Prague', 'class': 'OTHER'}, {'name': 'Institute for Clinical and Experimental Medicine', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Institute of Medical Biochemistry and Laboratory Diagnostics', 'investigatorFullName': 'Iva Subhanova', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}