Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-02-18 @ 3:16 AM
Study NCT ID:
NCT02904603
Status:
UNKNOWN
Last Update Posted:
2016-09-21
First Post:
2016-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Monitoring of Hepatitis C Under DAA Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum probes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2016-09-06', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of IP10 and related cytokines during treatment (ng/ml)', 'timeFrame': '24 weeks (observation time under and after DAA therapy)', 'description': 'Screening for Biomarkers under DAA Therapy until timepoint SVR 12 (12 weeks treatment plus control 12 weeks after end of Treatment = 24 weeks)'}], 'secondaryOutcomes': [{'measure': 'SVR 12', 'timeFrame': '24 weeks (12 weeks treatment plus control 12 weeks after end of treatment)', 'description': 'Eradication of HCV RNA 12 weeks after end of Treatment (Treatment 12 weeks)'}, {'measure': 'Change of inflammatory markers (ferritin ng/ml, CRP mg/l, PCT ng/ml) during treatment', 'timeFrame': '24 weeks (observation time under DAA therapy)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '33587435', 'type': 'DERIVED', 'citation': 'Adenugba A, Hornung M, Weigand K, Peschel G, Junger H, Kupke P, Lang H, Marquardt JU, Zimmermann T, Geissler EK, Schlitt HJ, Werner JM. Ribavirin Improves NK Cell IFNgamma Response During Sofosbuvir-based DAA Therapy in HCV-infected Liver Transplant Recipients. Transplantation. 2021 Oct 1;105(10):2226-2238. doi: 10.1097/TP.0000000000003612.'}, {'pmid': '29467758', 'type': 'DERIVED', 'citation': 'Hutchinson JA, Weigand K, Adenugba A, Kronenberg K, Haarer J, Zeman F, Riquelme P, Hornung M, Ahrens N, Schlitt HJ, Geissler EK, Werner JM. Predicting Early Viral Control under Direct-Acting Antiviral Therapy for Chronic Hepatitis C Virus Using Pretreatment Immunological Markers. Front Immunol. 2018 Feb 7;9:146. doi: 10.3389/fimmu.2018.00146. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Direct acting antivirals offer a new opportunity to monitor the immune response in Hepatitis C infection. In this study cytokine markers will be measured during therapy up to time point SVR 12 an correlated to clinical Parameters and regular laboratory findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients under DAA therapy \\> 18 years monocentral.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written consent, age, HCV-RNA positive, DAA therapy\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02904603', 'acronym': 'IMHC', 'briefTitle': 'Immune Monitoring of Hepatitis C Under DAA Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Regensburg'}, 'officialTitle': 'Prospective Monitoring of Immune Parameters in Patients With Hepatitis C Under Treatment With Direct Acting Antivirals', 'orgStudyIdInfo': {'id': 'IM-HC-1516'}}, 'contactsLocationsModule': {'locations': [{'zip': '93047', 'city': 'Regensburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Georg Peschel', 'role': 'CONTACT', 'email': 'georg.peschel@ukr.de', 'phone': '00499419447012'}, {'name': 'Kilian Weigand', 'role': 'CONTACT', 'email': 'kilian.weigand@ukr.de', 'phone': '00499419447012'}], 'facility': 'University of Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'centralContacts': [{'name': 'Georg Peschel', 'role': 'CONTACT', 'email': 'georg.peschel@ukr.de', 'phone': '00499419447012'}, {'name': 'Kilian Weigand', 'role': 'CONTACT', 'email': 'kilian.weigand@ukr.de', 'phone': '00499419447012'}], 'overallOfficials': [{'name': 'Kilian Weigand', 'role': 'STUDY_CHAIR', 'affiliation': 'Uiversity of Regensburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regensburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Dr. Georg Peschel', 'investigatorAffiliation': 'University of Regensburg'}}}}