Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-29 @ 11:59 PM
Study NCT ID:
NCT04048850
Status:
COMPLETED
Last Update Posted:
2025-01-28
First Post:
2019-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zepatier in Patients with Substance Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], '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': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589335', 'term': 'elbasvir'}, {'id': 'C578009', 'term': 'grazoprevir'}, {'id': 'C000611265', 'term': 'elbasvir-grazoprevir drug combination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2019-08-01', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SVR - PP', 'timeFrame': '12 weeks after the end of therapy (SVR-12)', 'description': 'Proportion of patients in the per-protocol (PP) population with sustained virologic response (SVR). PP: excludes non-treatment related discontinuations and patients lost to follow-up before SVR-12 laboratory test.'}], 'secondaryOutcomes': [{'measure': 'SVR - stratified', 'timeFrame': '12 weeks after the end of therapy (SVR-12)', 'description': 'PP SVR-12 stratified by pre-specified baseline characteristics:\n\n* HCV monoinfection\n* HIV-HCV co-infection\n* Cirrhosis\n* Positive baseline urine toxicology\n* Men who have sex with men (MSM)\n* Commercial sex work\n* Diagnosed concomitant psychiatric disorder(s)\n* Use of concomitant medication(s)\n* Specific substance(s) used'}, {'measure': 'Drug-Drug interactions (DDIs)', 'timeFrame': 'From enrollment to treatment completion or termination, which ever comes first, for up to 36 weeks', 'description': 'Interventions to prevent or remedy known or suspected DDIs between elbasvir/grazoprevir and concomitant prescription or over-the-counter medications, supplements, and substance of use'}, {'measure': 'Adherence', 'timeFrame': 'During 12 weeks of treatment', 'description': 'Self-reported adherence to elbasvir/grazoprevir, reported as number of missed doses and % missed doses of total doses'}, {'measure': 'SVR - ITT', 'timeFrame': '12 weeks after the end of therapy (SVR-12)', 'description': 'Proportion of patients in the intention-to-treat (ITT) population with SVR-12. ITT: all patients who received at least one dose of Zepatier (elbasvir/grazoprevir)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HCV', 'HIV-HCV coinfection', 'DAA', 'Elbasvir/grazoprevir'], 'conditions': ['Hepatitis C', 'Hiv', 'Coinfection, HIV', 'Substance Use Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://hospital.uillinois.edu/', 'label': 'University of Illinois at Chicago Hospital and Health Sciences System'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess hepatitis C virus (HCV) treatment with Zepatier (elbasvir/grazoprevir) in HCV monoinfected and human immunodeficiency virus (HIV)-HCV co-infected, HCV treatment-naïve or peginterferon/ribavirin-experienced patients with HCV genotype 1a, without baseline NS5A resistance, 1b, or 4 and substance use in urban, multidisciplinary specialty clinics.', 'detailedDescription': 'Previously, people who use substances and those without liver fibrosis or cirrhosis were excluded from receiving direct-acting antiviral (DAA) treatment due to Illinois Medicaid restrictions. These sobriety and staging restrictions were recently lifted. However, due to these previous stringent requirements for sobriety, many patients were not able to be treated for HCV. This created a data gap for real-world outcomes of HCV treatment in people who use substances. This study presents a unique opportunity to provide patients with hepatitis C treatment and obtain much needed data on the use of elbasvir/grazoprevir in patients with substance use and other underrepresented comorbidities. Additionally, this study will determine if our current standard of care for the treatment of HCV is effective for patients with substance use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The specific patient population to be studied is HCV monoinfected and HIV-HCV co-infected, HCV treatment-naïve or peginterferon/ribavirin-experienced patients of the UI Health Infectious Disease or Liver Clinic with HCV genotype 1a, without baseline NS5A resistance, 1b, or 4 and substance use treated with 12 weeks of elbasvir/grazoprevir therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (at least 18 years of age or older)\n* Chronic HCV (HCV antibody positive with detectable HCV-RNA)\n* HCV genotypes 1a, without the presence of baseline NS5A resistance (specifically, polymorphisms at amino acid positions 28, 30, 31, or 93), 1b, or 4\n* HCV treatment-naïve or peginterferon/ribavirin-experienced\n* Managed by the UI Health Infectious Diseases Clinic or Liver Clinic\n* Recent or current substance use (per self-report or electronic medical record (EMR) data within 90 days of the screening visit, with or without positive baseline urine toxicology), inclusive of one or more of the following: Opiate substitution therapy; Prescription medication misuse (including: opiates, sedatives, tranquilizers, hypnotics, and psychostimulants); Illicit substances; Injection drug use; Alcohol\n\nExclusion Criteria:\n\n* Incarcerated\n* Pregnant or breastfeeding\n* Decompensated liver disease (Child-Pugh B or C)\n* Albumin below 3 g/dL\n* Platelet count below 75,000\n* Unwilling to commit to treatment and/or monitoring\n* Poor venous access inhibiting laboratory collection\n* Any condition considered by the investigators to be a contraindication to study participation\n* Hepatitis B virus (HBV) surface antigen (HBsAg) positive'}, 'identificationModule': {'nctId': 'NCT04048850', 'briefTitle': 'Zepatier in Patients with Substance Use', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Cohort Study of Hepatitis C Virus Treatment with Zepatier (Elbasvir/Grazoprevir) in Genotype 1 or 4 HCV Treatment-Naïve or Peginterferon/Ribavirin-Experienced Patients with Substance Use in Urban, Multidisciplinary Specialty Clinics', 'orgStudyIdInfo': {'id': '2019-0478'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients living with HCV +/- HIV', 'description': 'HCV monoinfected and human immunodeficiency virus (HIV)-HCV co-infected, HCV treatment-naïve or peginterferon/ribavirin-experienced patients with HCV genotype 1a, without baseline NS5A resistance, 1b, or 4 and substance use treated with elbasvir/grazoprevir 50-100 mg fixed-dose-combination, 1 tablet by mouth daily, for 12 weeks.', 'interventionNames': ['Drug: Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]']}], 'interventions': [{'name': 'Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]', 'type': 'DRUG', 'otherNames': ['Zepatier'], 'description': 'Daily medication', 'armGroupLabels': ['Patients living with HCV +/- HIV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Rodrigo Mauricio Burgos, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago College of Pharmacy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Rodrigo Mauricio Burgos', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}