Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT03407703
Status:
UNKNOWN
Last Update Posted:
2018-04-18
First Post:
2018-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hepatitis C (HCV) Cure and Kidney Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-30', 'releaseDate': '2024-05-01'}], 'estimatedResultsFirstSubmitDate': '2024-05-01'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589335', 'term': 'elbasvir'}, {'id': 'C578009', 'term': 'grazoprevir'}, {'id': 'C000611265', 'term': 'elbasvir-grazoprevir drug combination'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma and PBMC (peripheral blood mononuclear cell)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2018-01-09', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glomerular filtration rate and injury', 'timeFrame': '1 year', 'description': 'measured by Cystatin C'}, {'measure': 'glomerular filtration rate and injury', 'timeFrame': '1 year', 'description': 'measured by Creatinine'}, {'measure': 'glomerular filtration rate and injury', 'timeFrame': '1 year', 'description': 'measured by albuminuria'}, {'measure': 'Tubule dysfunction', 'timeFrame': '1 year', 'description': 'measured by α1-microglobulin'}, {'measure': 'Tubule dysfunction', 'timeFrame': '1 year', 'description': 'measured by beta2-microglobulin'}, {'measure': 'Tubule injury', 'timeFrame': '1 year', 'description': 'measured by Interleukin-18'}, {'measure': 'tubule injury', 'timeFrame': '1 year', 'description': 'measured by Kidney injury molecule-1'}, {'measure': 'tubule injury', 'timeFrame': '1 year', 'description': 'measured by Neutrophil gelatinase-associated lipocalcin (NGAL)'}, {'measure': 'tubule injury', 'timeFrame': '1 year', 'description': 'measured by Clusterin'}, {'measure': 'tubule injury', 'timeFrame': '1 year', 'description': 'measured by Trefoil factor-3 (TFF-3)'}], 'secondaryOutcomes': [{'measure': 'HCV clearance', 'timeFrame': '1 year', 'description': 'measured by HCV viral load'}, {'measure': 'liver fibrosis', 'timeFrame': '1 year', 'description': 'liver stiffness measured by transient elastography'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['genotype 1', 'genotype 4'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn how 12 weeks of HCV treatment with elbasvir and grazoprevir (brand name Zepatier) impacts your kidney function.', 'detailedDescription': "Prospective data collection of 25 Genotype 1 or 4 HCV-infected women from the San Francisco Women's Interagency HIV Study (WIHS) site and 25 Genotype 1 or 4 HCV-infected men from the San Francisco VA Medical Center who are initiated on Zepatier for 12 weeks (Total n=50). For women and men with HCV genotype 1a infection, only those without baseline NS5A resistance mutations will be included. Blood/urine samples will be collected before initiation of treatment, 4 weeks after treatment initiation, 12 weeks after treatment initiation (end of treatment), 24 weeks after treatment initiation to determine Sustained Virological Response (SVR), and at 48 weeks after treatment initiation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '25 Genotype 1 or 4 HCV-infected women from the San Francisco WIHS site and 25 Genotype 1 or 4 HCV-infected men from the San Francisco VA Medical Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Active Genotype 1 or 4 HCV infection (If with Genotype 1a infection, only those without baseline NS5A resistance mutation will be included; Genotype 4 HCV infection is uncommon in both study populations). Subjects with HIV coinfection are included. We will not exclude patients who have severe Chronic Kidney Disease, are on dialysis, or have undergone kidney transplant.\n\nExclusion Criteria:\n\n1. HCV genotype 2, 3, 5, or 6 infection\n2. Previous virologic failure to regimens containing an NS5A inhibitor\n3. Decompensated liver disease (Child-Pugh Class B or C)\n4. Albumin below 3g/dL\n5. Platelet count below 75,000\n6. Any condition that the investigator considers a contraindication to study participation including limited life expectancy\n7. Pregnant or breastfeeding woman\n8. Hepatitis B virus (HBV) surface antigen positive (Note: Patients positive for the HBV core antibody will not be excluded, but will have HBV DNA levels checked and will be monitored while on Direct Acting Antivirals (DAA) therapy and medically managed as considered appropriate)\n9. Documented ongoing nonadherence to prescribed medications or medical treatment, failure to complete HCV disease evaluation appointments and procedures or unable to commit to scheduled followup/monitoring for the duration of treatment\n10. Poor venous access not allowing screening laboratory collection\n11. Known hypersensitivity to elbasvir/grazoprevir\n12. Co-administration with drugs that are 1) strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin); 2) OATP1B1/3 inhibitors (e.g., cyclosporine, darunavir, atazanavir, tipranavir, lopinavir or saquinavir) or 3) efavirenz'}, 'identificationModule': {'nctId': 'NCT03407703', 'briefTitle': 'Hepatitis C (HCV) Cure and Kidney Health', 'organization': {'class': 'FED', 'fullName': 'San Francisco Veterans Affairs Medical Center'}, 'officialTitle': 'HCV Cure and Kidney Health: A Prospective, Observational Cohort Study of HCV Genotype 1 and 4 Infected Adults With and Without HIV Infection', 'orgStudyIdInfo': {'id': '17-22790'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Elbasvir / Grazoprevir Oral Tablet [Zepatier]', 'type': 'DRUG', 'description': 'HCV treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Phyllis C Tien, MD', 'role': 'CONTACT', 'email': 'phyllis.tien@ucsf.edu', 'phone': '415-221-4810', 'phoneExt': '22577'}, {'name': 'Heather Freasier, MS', 'role': 'CONTACT', 'email': 'heather.freasier@ucsf.edu', 'phone': '415-379-5518'}], 'facility': 'San Francisco VA Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Phyllis C Tien, MD', 'role': 'CONTACT', 'email': 'phyllis.tien@ucsf.edu', 'phone': '415-221-4810', 'phoneExt': '22577'}, {'name': 'Heather S Freasier, MS', 'role': 'CONTACT', 'email': 'heather.freasier@ucsf.edu', 'phone': '415-379-5518'}], 'overallOfficials': [{'name': 'Phyllis C Tien, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Francisco VA Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Francisco Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Clinical Pharmacy and Staff Physician', 'investigatorFullName': 'Phyllis Tien', 'investigatorAffiliation': 'San Francisco Veterans Affairs Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-05-01', 'type': 'RELEASE'}, {'date': '2024-07-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Phyllis Tien, Professor of Medicine and Clinical Pharmacy and Staff Physician, San Francisco Veterans Affairs Medical Center'}}}}