Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-25 @ 1:04 PM
Study NCT ID:
NCT01062659
Status:
WITHDRAWN
Last Update Posted:
2014-04-01
First Post:
2010-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cellular Immune Responses in the Liver in Chronic Hepatitis C (CHC) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-31', 'studyFirstSubmitDate': '2010-02-03', 'studyFirstSubmitQcDate': '2010-02-03', 'lastUpdatePostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HCV', 'hepatitis C virus', 'CHC', 'chronic hepatitis c', 'interferon', 'ribavirin', 'Hepatitis, Viral, Human', 'Anti-Infective Agents', 'peginterferon alfa-2a', 'peginterferon alfa-2b'], 'conditions': ['Hepatitis C, Chronic', 'Liver Diseases', 'Virus Diseases']}, 'descriptionModule': {'briefSummary': 'In order to persist in the liver, HCV has numerous nonspecific and specific strategies to overcome the immunity of the host. The crucial step in the establishment of viral persistence and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the liver. Treatment with pegylated interferon alpha (IFNα) in combination with ribavirin (RBV) is the standard therapy for chronic hepatitis C is. The response to IFNα / RBV therapy depends on the effective cellular antiviral immune response in the liver. The understanding of the interaction between HCV and cellular immune response is important for the effective use of existing diagnostic techniques, the Individual control and adjustment of the current therapeutic approaches and the development of future therapeutic and immunization strategies. In this study, the investigators want to investigate cellular Immune responses in the liver of HCV infected patients and characterize the influence of these immune responses to the response to IFNα / RBV therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patient with established chronic hepatitis C presented to the liver unit of the outpatient clinic how are eligible to antiviral therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* proven chronic hepatitis C\n* aged between 18 and 65\n* willingness to give written informed consent to the study protocol\n\nExclusion Criteria:\n\n* history of having received any IFN, PEG-IFN or RBV\n* not eligible for antiviral treatment with peginterferon and ribavirin by standard of care'}, 'identificationModule': {'nctId': 'NCT01062659', 'briefTitle': 'Cellular Immune Responses in the Liver in Chronic Hepatitis C (CHC) Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Characterization of Cellular Immune Responses in the Liver in Patients With Chronic Hepatitis C Virus Infection', 'orgStudyIdInfo': {'id': 'TCell'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic Hepatitis C', 'description': 'Patients with chronic Hepatitis C (CHC) Genotype 1-4 who are naive to antiviral treatment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulm', 'country': 'Germany', 'facility': 'University Hospital Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Dietmar M Klass, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Dietmar M. Klass', 'investigatorAffiliation': 'University of Ulm'}}}}