Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-01-03 @ 8:06 PM
Study NCT ID:
NCT02528461
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2015-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], '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'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005690', 'term': 'Galactose'}, {'id': 'D005773', 'term': 'Gastroscopy'}, {'id': 'D000069474', 'term': 'Sofosbuvir'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2015-08-14', 'studyFirstSubmitQcDate': '2015-08-18', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the macrophage activation markers sCD163 and sCD206', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Changes in liver fibrosis with fibroscan', 'timeFrame': '1 year', 'description': 'Liver fibrosis will be determined using fibroscan, and reported as changes in the amount of fibrosis in the liver'}, {'measure': 'Changes in histological liver fibrosis', 'timeFrame': '1 year', 'description': 'Liver fibrosis will be also be determined on liver biopsies. Determining changes in fibrosis from baseline to after treatment.'}, {'measure': 'Changes in clinical status', 'timeFrame': '1 year', 'description': 'Defined by the number of patients with the occurrence of cirrhosis complications, eg. ascites, hepatic encephalopathy, variceal bleeding.'}, {'measure': 'Changes in hepatic venous pressure', 'timeFrame': '1 year', 'description': 'Hepatic venous pressure will be assessed with liver vein catheterization before and after treatment and the results reported as changes between baseline and after treatment.'}, {'measure': 'Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test', 'timeFrame': '1 year', 'description': 'GEC will be applied before and after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sofosbuvir', 'Direct acting anti-viral treatment', 'liver cirrhosis'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to investigate how the liver is affected with regard to inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.\n\nIn order to examine how the liver heals, we want to use blood samples to check for the occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of ultrasound examination) and also preferably with extraction of a small tissue sample. We want to examine how the liver function as inflammation and scar tissue decrease, especially concerning the liver's ability to produce proteins. Furthermore, we want to examine with a gastroscopy, if the circulation of blood in the liver is improved after successful treatment with the expected result that potential varicose veins in the esophagus vanish."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic hepatitis C initiating sofosbuvir-based direct-acting antiviral treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hepatitis C and initiation of sofosbuvir-based direct-acting antiviral treatment\n\nExclusion Criteria:\n\n* HIV or Hepatitis B Virus'}, 'identificationModule': {'nctId': 'NCT02528461', 'briefTitle': 'Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Measuring Inflammation Cells (CD163 and CD206) With the Purpose of Examining Reduction of Fibrosis in the Liver of Chronic Hepatitis C Patients Following Treatment With the Medication Sofosbuvir', 'orgStudyIdInfo': {'id': 'HCV sCD163 Sofosbuvir'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sofosbuvir', 'description': 'All patients receiving Sofosbuvir based treatment regimes during the study period will be included in the study.\n\nAll patients will receive all interventions (galactose elimination capacity test, gastroscopy, fibroscan), except liver biopsy which the patients may decline to participate in without affecting the participation in the rest of the study. If varices are found during the gastroscopy a liver vein catheterization will be performed.', 'interventionNames': ['Drug: Galactose', 'Procedure: Gastroscopy', 'Procedure: Liver biopsy', 'Procedure: Fibroscan', 'Procedure: Liver vein catheterization', 'Drug: Sofosbuvir']}], 'interventions': [{'name': 'Galactose', 'type': 'DRUG', 'otherNames': ['GEC'], 'description': "A test to investigate the liver's ability to metabolize galactose to glucose by injecting galactose followed by measurements of blood glucose and the quantification of galactose in the urine.", 'armGroupLabels': ['Sofosbuvir']}, {'name': 'Gastroscopy', 'type': 'PROCEDURE', 'armGroupLabels': ['Sofosbuvir']}, {'name': 'Liver biopsy', 'type': 'PROCEDURE', 'armGroupLabels': ['Sofosbuvir']}, {'name': 'Fibroscan', 'type': 'PROCEDURE', 'armGroupLabels': ['Sofosbuvir']}, {'name': 'Liver vein catheterization', 'type': 'PROCEDURE', 'armGroupLabels': ['Sofosbuvir']}, {'name': 'Sofosbuvir', 'type': 'DRUG', 'armGroupLabels': ['Sofosbuvir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'overallOfficials': [{'name': 'Henning Grønbæk, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}