Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-21 @ 4:54 PM
Study NCT ID:
NCT03659058
Status:
COMPLETED
Last Update Posted:
2018-11-27
First Post:
2018-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012838', 'term': 'Silymarin'}, {'id': 'D014580', 'term': 'Ursodeoxycholic Acid'}, {'id': 'D000975', 'term': 'Antioxidants'}, {'id': 'D003078', 'term': 'Colchicine'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D044947', 'term': 'Flavonolignans'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '200 patients will receive silymarin 420 mg + antioxidants + colchicine'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-23', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2018-09-01', 'lastUpdatePostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in liver stiffness measurement by Fibroscan', 'timeFrame': '1 year', 'description': 'Liver stiffness assessment by Fibroscan every 6 months'}, {'measure': 'Improved portal hypertension parameters', 'timeFrame': '1 year', 'description': 'Assessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months'}, {'measure': 'Improved splenic stiffness measurement', 'timeFrame': '1 year', 'description': 'assessment by ultrasound and fibroscan'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fibrosis', 'HCV', 'Reversal', 'sustained virological response'], 'conditions': ['Fibrosis, Liver']}, 'descriptionModule': {'briefSummary': 'with the introduction of Direct-acting antiviral agents in the management of HCV, the scope of inclusion criteria had been widened to include patients with compensated cirrhosis and even in special situations patients with decompensated liver disease; a chance that was not offered by the limited and strict inclusion criteria needed for treatment by pegylated interferon-based regimen. this made the number of patients with progressive liver fibrosis of cirrhosis had been inv=creased even after achieving SVR. the debate about the impact of SVR on halting fibrosis progression had risen; some studies postulated that patients benefit from an SVR through reduction of mortality, morbidity, and improved quality of life ; however, some patients may maintain their level of fibrosis or even progress to cirrhosis despite achieving SVR and the risk for HCC remains even after virologic eradication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic HCV\n* compensated liver disease (Child class A-B)\n* sustained virological response\n* liver stiffness by fibroscan \\>12.5 kPa denotes cirrhosis\n\nExclusion Criteria:\n\n* decompensated liver disease\n* chronic active HCV\n* hepatocellular carcinoma\n* other liver diseases as alcoholic liver disease, autoimmune liver disease, drug-induced liver disease\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03659058', 'acronym': 'fib-reversal', 'briefTitle': 'Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After Achieving Sustained Virological Response', 'orgStudyIdInfo': {'id': '37801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'study group', 'description': '200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be treated by anti-fibrotic agents', 'interventionNames': ['Drug: silymarin', 'Drug: Ursodeoxycholic Acid', 'Drug: Antioxidants', 'Drug: Colchicine', 'Other: FOLLOW UP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': '200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be followed up without any intervention', 'interventionNames': ['Other: FOLLOW UP']}], 'interventions': [{'name': 'silymarin', 'type': 'DRUG', 'otherNames': ['silymarin 140'], 'description': 'silymarin 140 three times daily', 'armGroupLabels': ['study group']}, {'name': 'Ursodeoxycholic Acid', 'type': 'DRUG', 'otherNames': ['ursofalk'], 'description': 'Ursodeoxycholic Acid 500', 'armGroupLabels': ['study group']}, {'name': 'Antioxidants', 'type': 'DRUG', 'otherNames': ['antox'], 'description': 'Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg', 'armGroupLabels': ['study group']}, {'name': 'Colchicine', 'type': 'DRUG', 'description': 'Colchicine 0.6', 'armGroupLabels': ['study group']}, {'name': 'FOLLOW UP', 'type': 'OTHER', 'otherNames': ['ultrasound and fibroscan'], 'description': 'follow up by abdominal ultrasound and fibroscan every 6 month for 1 year', 'armGroupLabels': ['control group', 'study group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of medicine', 'investigatorFullName': 'Amr Shaaban Hanafy', 'investigatorAffiliation': 'Zagazig University'}}}}