Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-04 @ 10:18 PM
Study NCT ID:
NCT03908294
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change of Glucose Metabolism and Fibrosis Markers in Patients With Hepatitis C Under Treatment With Antiviral Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients with changes in glucose metabolism measured by fasting glucose', 'timeFrame': 'From baseline up to one year after end of treatment', 'description': 'rate of patients with normal fasting glucose (\\<100mg/dl), prediabetes (glucose 100-125mg/d) and diabetes (\\>126mg/dl)'}, {'measure': 'Rate of patients with changes in glucose metabolism measured by Homeostasis Model Assessment-index (HOMA)', 'timeFrame': 'From baseline up to one year after end of treatment', 'description': 'Homeostasis Model Assessment-index (HOMA) measures insulin resistance:\n\n1. \\<2,0 insulin resistance unlikely\n2. 2,0 - 2,5 insulin resistance possible\n3. 2,5 - 5,0 insulin resitance likely\n4. \\>5,0 proven insulin resitance'}, {'measure': 'Rate of patients with changes in glucose metabolism measured by HbA1c', 'timeFrame': 'From baseline up to one year after end of treatment', 'description': 'rate of patients with normal HbA1c (\\>6% Hb), prediabetes (6-6.4% Hb) and diabetes (\\>6.5% Hb)'}], 'secondaryOutcomes': [{'measure': 'Liver fibrosis 1', 'timeFrame': 'From baseline up to one year after end of treatment', 'description': 'Evaluation of changes of parameters reflecting liver fibrosis: Fibroscan'}, {'measure': 'Liver fibrosis 2', 'timeFrame': 'From baseline up to one year after end of treatment', 'description': 'Evaluation of changes of parameters reflecting liver fibrosis: ARFI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glucose Metabolism Disorders', 'Liver Fibrosis', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'Chronic hepatitis C infection is associated with changes of glucose metabolism end increased frequency of impaired glucose tolerance. This might be a additional risk factor for disease and fibrosis progression. The study aims to evaluate whether a therapy with direct-acting antiviral agents leading to a sustained virologic response directly impacts parameters reflecting glucose metabolism and fibrosis.', 'detailedDescription': 'Chronic hepatitis C infection is associated with changes of glucose metabolism end increased frequency of impaired glucose tolerance. It is well known that metabolic factors play an important role in fibrosis progression and steatohepatitis for example in non-alcoholic steatohepatitis (NASH). Accordingly changes in glucose metabolism in patients with chronic hepatitis C might directly impact disease and fibrosis progression. The study aims to evaluate whether a therapy with direct-acting antiviral agents leading to a sustained virologic response directly impacts parameters reflecting glucose metabolism and fibrosis. Follow-up examinations will determine the long-term metabolic changes of successful elimination of the virus by antiviral treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic hepatitis C infection with planned antiviral DAA treatment', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with chronic hepatitis C infection and planned antiviral therapy with direct-acting antiviral agents\n2. Age 18-99\n3. Informed Consent\n\nExclusion Criteria:\n\n1. Patients without legal capacity for informed consent\n2. alcohol intake ≥ 20 g/d (f) und 30 g/d (m) within one year of study screening\n3. Decompensated cirrhosis\n4. viral co-infection\n5. HIV infection\n6. Non-viral chronic liver disease\n7. Malignancy within 5 years before study screening except basalioma\n8. liver transplant recipients\n9. weight loss ≥10% within 3 months before study screening\n10. Changes of diabetic drug treatment, lipid lowering therapy oder vitamin E within three months before study screening.\n11. Intake of medication associated with hepatic steatosis (e.g. steroids, methotrexate, amiodarone, tamoxifen, valproat, flutamide, tetracyclins, cytostatics etc.)\n12. Bariatric surgery in personal history\n13. Clinically relevant congestive heart disease, cardiac arrythmia, valvular heart disease)\n14. Implanted cardiac pacemaker or defibrillator\n15. Patients during pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT03908294', 'briefTitle': 'Change of Glucose Metabolism and Fibrosis Markers in Patients With Hepatitis C Under Treatment With Antiviral Agents', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Examination of Changes of Parameters of Glucose Metabolism and Liver Fibrosis Stadium by Acoustic Radiation Force Impulse-Imaging and Transient Elastography in Patients With Chronic Hepatitis C Under Antiviral Treatment', 'orgStudyIdInfo': {'id': 'JWGUHMED1-012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic hepatitis C under antiviral treatment with DAA', 'description': 'Patients with chronic hepatitis C infection and planned DAA treatment are enrolled prospectively. Parameters of glucose metabolism and liver fibrosis are measured at baseline, during therapy and up to one year after end of treatment.', 'interventionNames': ['Diagnostic Test: Lab tests, non-invasive fibrosis (Fibroscan/ARFI)']}], 'interventions': [{'name': 'Lab tests, non-invasive fibrosis (Fibroscan/ARFI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patient characteristics, lab values reflecting glucose metabolism and non-invasive fibrosis tests are documented at baseline, during therapy and up to one year after end of treatment.', 'armGroupLabels': ['Chronic hepatitis C under antiviral treatment with DAA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Klinikum der J. W. Goethe-Universität', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Tania Welzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Georg Dultz', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}