Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT03480932
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2018-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C]
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D023801', 'term': 'Directly Observed Therapy'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smehta@jhu.edu', 'phone': '4432873837', 'title': 'Dr. Shruti Mehta', 'organization': 'Johns Hopkins Bloomberg School of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Adherence measurements differ by arm (Arm 1 and 2 included daily observation of doses). Adherence assessment for Arm 3 based on participant completing a visit to pick up medication refill.'}}, 'adverseEventsModule': {'timeFrame': '16 weeks for Arm 1 and 24 weeks for ARms 2 and 3', 'eventGroups': [{'id': 'EG000', 'title': 'SOF+DAC+PEG', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nPegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SOF+DAC, DOT', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SOF+DAC, Standard', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SVR12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+DAC+PEG', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nPegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C'}, {'id': 'OG001', 'title': 'SOF+DAC, DOT', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C'}, {'id': 'OG002', 'title': 'SOF+DAC, Standard', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after treatment completion, 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC', 'description': 'Percentage of participants achieving sustained virologic response 12 weeks quantification) after treatment is completed (SVR12) as assessed by HCV RNA less than the lower limit of quantification measured 12 weeks after treatment completion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+DAC+PEG', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nPegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C'}, {'id': 'OG001', 'title': 'SOF+DAC, DOT', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C'}, {'id': 'OG002', 'title': 'SOF+DAC, Standard', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC', 'description': 'Number of participants with treatment-related serious adverse events by laboratory tests and physician examination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+DAC+PEG', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nPegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C'}, {'id': 'OG001', 'title': 'SOF+DAC, DOT', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C'}, {'id': 'OG002', 'title': 'SOF+DAC, Standard', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks for SOF+DAC+PEG and 12 weeks for SOF+DAC', 'description': 'Adherence to medication regimen defined using a combination of the biometric data for Arms 1 and 2 and self-report and pill counts for Arm 3. Percentage reporting at least 90% adherence', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SOF+DAC+PEG', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nPegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C'}, {'id': 'FG001', 'title': 'SOF+DAC, DOT', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C'}, {'id': 'FG002', 'title': 'SOF+DAC, Standard', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'SOF+DAC+PEG', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nPegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C'}, {'id': 'BG001', 'title': 'SOF+DAC, DOT', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C'}, {'id': 'BG002', 'title': 'SOF+DAC, Standard', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)\n\nSofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C\n\nDaclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '31'}, {'value': '26', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '31'}, {'value': '25', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '30'}, {'value': '25', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Indian', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Educational attainment', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Primary school', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}, {'title': 'Secondary school', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'At least high school', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment', 'classes': [{'categories': [{'title': 'Monthly wages', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'Weekly wages', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Daily wages', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}, {'title': 'Unemployment', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital status', 'classes': [{'categories': [{'title': 'Never married', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}, {'title': 'Currently married', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Separated', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Living with partner', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Injection drug use frequency in prior month', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Once a week to less than twice a week', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'Twice a week to six times a week', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': 'Daily', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Non-injection drug use in prior month', 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol use', 'classes': [{'categories': [{'title': 'No/mild use', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Harmful/hazardous use', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Alcohol dependence', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Depressive symptoms', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}, {'title': 'Mild', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Moderately severe to severe', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Quality of life', 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '78', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '95'}, {'value': '80', 'groupId': 'BG002', 'lowerLimit': '60', 'upperLimit': '96'}, {'value': '80', 'groupId': 'BG003', 'lowerLimit': '60', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'description': "Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale. The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine' with values from 100 to 0. This outcome reported here is based on the EQ VAS which ranges from 0 to 100", 'unitOfMeasure': 'Self-rated health scale (0-100))', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'HIV-infected', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Median HCV RNA', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'BG000', 'lowerLimit': '4.1', 'upperLimit': '6.3'}, {'value': '5.6', 'groupId': 'BG001', 'lowerLimit': '4.3', 'upperLimit': '6.2'}, {'value': '5.7', 'groupId': 'BG002', 'lowerLimit': '5.1', 'upperLimit': '6.5'}, {'value': '5.6', 'groupId': 'BG003', 'lowerLimit': '4.4', 'upperLimit': '6.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'log 10 copies/ml', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Median calculated fibrosis score (FIB-4)', 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'groupId': 'BG000', 'lowerLimit': '0.51', 'upperLimit': '0.88'}, {'value': '0.68', 'groupId': 'BG001', 'lowerLimit': '0.47', 'upperLimit': '1.12'}, {'value': '0.73', 'groupId': 'BG002', 'lowerLimit': '0.54', 'upperLimit': '1.14'}, {'value': '0.68', 'groupId': 'BG003', 'lowerLimit': '0.49', 'upperLimit': '1.08'}]}]}], 'paramType': 'MEDIAN', 'description': 'Fibrosis-4 (FIB-4) is a non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4). Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: FIB-4 = (Age \\[years\\] x AST \\[U/L\\]) / (platelets \\[10\\^9/L\\] x (square root of ALT \\[U/L\\])). A FIB-4 index of \\< 1.45 indicated no or moderate fibrosis and an index of \\> 3.25 indicated extensive fibrosis/cirrhosis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-25', 'size': 241018, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-07T21:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2018-01-29', 'resultsFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-26', 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SVR12', 'timeFrame': '12 weeks after treatment completion, 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC', 'description': 'Percentage of participants achieving sustained virologic response 12 weeks quantification) after treatment is completed (SVR12) as assessed by HCV RNA less than the lower limit of quantification measured 12 weeks after treatment completion'}], 'secondaryOutcomes': [{'measure': 'Serious Adverse Events', 'timeFrame': '16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC', 'description': 'Number of participants with treatment-related serious adverse events by laboratory tests and physician examination'}, {'measure': 'Medication Adherence', 'timeFrame': '4 weeks for SOF+DAC+PEG and 12 weeks for SOF+DAC', 'description': 'Adherence to medication regimen defined using a combination of the biometric data for Arms 1 and 2 and self-report and pill counts for Arm 3. Percentage reporting at least 90% adherence'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['directly observed therapy', 'sofosbuvir', 'daclatasvir', 'pegylated interferon', 'resource-limited setting'], 'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'The primary objective of this pilot trial is to compare the efficacy, measured as sustained virologic response (SVR) at least 12 weeks after completion of therapy, across three study regimens/delivery modalities: Arm 1 - 4 weeks of sofosbuvir (SOF) + daclatasvir (DAC) + pegylated interferon alfa-2a (PEG) delivered using directly observed therapy (DOT); Arm 2 - 12 weeks of SOF+DAC delivered using DOT; and Arm 3 - 12 weeks of SOF+DAC delivered as per standard of care (monthly dispensation with no DOT). Secondary objectives are 1)To compare the cost per SVR for each of the three study arms; 2) To compare adherence among persons across the three study arms; 3) To evaluate the safety, tolerability and acceptability of treatment in the three arms.', 'detailedDescription': 'This will be a non-blinded randomized clinical trial with 150 participants randomized at a 1:1:1 allocation ratio to one of three treatment arms.\n\nArm 1: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach\n\nArm 2: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach\n\nArm 3: Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)\n\nPegylated-interferon alfa-2a (PEG) will be delivered subcutaneously once weekly. Sofosbuvir (SOF) and Daclatasvir (DAC) will be taken orally once daily for the entire study period.\n\nThe study will take place at the YR Gaitonde Centre for AIDS Education (YRG) and Johns Hopkins University (JHU) Collaborative Integrated Care Center (YRG-JHU ICC) located within the premises of the Chattisgarh Institute of Medical Sciences (CIMS) in Bilaspur in the state of Chattisgarh, India.\n\nParticipants will be recruited from the YRG-JHU ICC in Bilaspur, which currently has 514 registered HCV antibody positive clients. The Bilaspur ICC is in the Chattisgarh Institute for Medical Sciences (CIMS).\n\nThe primary outcome will be sustained virologic response (SVR12). Secondary outcomes include cost per SVR12, adherence, safety and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Willing and able to provide written informed consent\n2. Age ≥ 18 years\n3. Documented evidence of chronic HCV infection (HCV RNA positive)\n4. Participant is a resident of Bilaspur and can provide locator information that can be verified by one of the study staff\n5. If participant is co-infected with HIV, he/she must have a cluster of differentiation 4 (CD4) \\> 350 cells/mm3 and be either: 1) antiretroviral therapy (ART) naïve or 2) on ART be on a tenofovir-containing regimen. If a subject's CD4 drops below 350 cells/μl (current threshold for HIV treatment in India), he/she will be able to initiate ART but we will ensure that the subject starts on a tenofovir-containing regimen, which is currently the standard for persons newly initiating ART in India.\n6. Subjects must have the following laboratory parameters at screening:\n\n 1. alanine aminotransferase (ALT) ≤ 10 x the upper limit of normal (ULN)\n 2. aspartate aminotransferase (AST) ≤ 10 x ULN\n 3. Hemoglobin ≥ 10 g/dl for male and 9 g/dl for female subjects\n 4. International normalized ratio (INR) ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR\n 5. Albumin ≥ 3 g/dl\n 6. Direct bilirubin ≤ 1.5 x ULN\n 7. Creatinine clearance ≥ 30 ml/min as calculated by the Cockcroft-Gault Equation\n 8. Alpha fetoprotein \\< 50 ng/ml\n 9. Absolute neutrophil count (ANC) ≥ 1,500/μL\n 10. Platelets ≥ 90,000/μL\n 11. Thyroid stimulating hormone (TSH) ≤ ULN\n 12. FIB-4 \\<3.25. FIB-4 is a non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) which is calculated as the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: FIB-4 = (Age \\[years\\] x AST \\[U/L\\]) / (platelets \\[10\\^9/L\\] x (square root of ALT \\[U/L\\])). A FIB-4 index of \\< 1.45 indicated no or moderate fibrosis and an index of \\> 3.25 indicated extensive fibrosis/cirrhosis.) Participants with a FIB-4 \\>3.25 will be referred to the medical gastroenterology department for further assessment for cirrhosis. If cirrhosis is ruled out by medical gastroenterology, participants can be rescreened for the study.\n7. A female subject is eligible to enroll in the study if it is confirmed that she is:\n\n 1. Not pregnant or nursing\n 2. Not of childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed or medically documented ovarian failure, or are postmenopausal women \\> 50 years of age with cessation (for ≥12 months) of previously occurring menses)\n 3. Of childbearing potential (i.e., women who have not had a hysterectomy, both ovaries removed or medically documented ovarian failure). \\[NOTE: Women ≤50 years of age with amenorrhea will be considered to be of childbearing potential.\\] These women must have a negative urine pregnancy test at screening and a negative urine pregnancy test on the Baseline /Day 1 visit prior to randomization and agree to one of the following modes of contraception for the duration of treatment and 12 weeks thereafter.\n\n * Complete abstinence from intercourse. Periodic abstinence (e.g., calendar, ovulation, sumptothermal, post-ovulation methods) is NOT permitted.\n\n or\n\n i. Consistent and correct use of 1 of the following methods of birth control listed below in addition to a male partner who correctly uses a condom from 3 weeks prior to Baseline/Day 1 until the end of treatment. Women of childbearing potential must not rely on hormone-containing contraceptives as a form of birth control during the study. Female subjects using a hormone containing contraceptive prior to screening may continue their contraceptive regimen in addition to the study specified methods of birth control.\n * intrauterine device (IUD) with a documented failure rate of less than 1% per year\n * female barrier method: cervical cap or diaphragm with spermicidal agent\n * tubal sterilization\n * vasectomy in male partner\n8. Subjects must be of generally good health as determined by the investigator.\n9. Subjects must be able to comply with the dosing instructions for study drug administration and be willing to complete the study schedule of assessments.\n\nExclusion Criteria:\n\n1. Pregnant or nursing female\n2. Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage, model for end-stage liver disease (MELD)\\<12)\n3. Prior treatment for hepatitis C virus infection\n4. Infection with hepatitis B virus (HBsAg positive)\n5. Chronic use of systematically administered immunosuppressive agents (e.g., prednisone equivalent \\>10 mg/day)\n6. Use of any prohibited concomitant medications within 28 days of the Baseline/Day 1 visit.\n7. Contraindications to PEG\n8. Known hypersensitivity to the metabolites or formulation excipients of PEG (for Arm 1 subjects)\n9. Active significant psychiatric condition(s) including severe depression, severe bipolar disorder and schizophrenia. Other psychiatric disorders are permitted if the condition is well controlled with a stable treatment regimen for ≥ 1 year from screening, or inactive for ≥ 1 year from screening.\n10. Presence of autoimmune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, psoriasis of greater than mild severity)\n11. History of clinical significant retinal disease\n12. Clinical evidence of cirrhosis"}, 'identificationModule': {'nctId': 'NCT03480932', 'briefTitle': 'Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C]', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Role of Pegylated Interferon in Combination With Direct Acting Antivirals (DAAs) to Cure Hepatitis C As Soon As Possible (ASAP) - Hepatitis C [ASAP-C]', 'orgStudyIdInfo': {'id': 'R01DA026727', 'link': 'https://reporter.nih.gov/quickSearch/R01DA026727', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DA026727', 'link': 'https://reporter.nih.gov/quickSearch/R01DA026727', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SOF+DAC+PEG', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Daclatasvir', 'Drug: Pegylated Interferon alfa-2a']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOF+DAC, DOT', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Daclatasvir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOF+DAC, standard', 'description': 'Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Daclatasvir']}], 'interventions': [{'name': 'Sofosbuvir', 'type': 'DRUG', 'otherNames': ['Sovaldi', 'Hepcvir', 'MyHep', 'Hepcinat', 'Resof', 'SoviHep'], 'description': 'Direct acting antiviral agent used for the treatment of hepatitis C', 'armGroupLabels': ['SOF+DAC+PEG', 'SOF+DAC, DOT', 'SOF+DAC, standard']}, {'name': 'Daclatasvir', 'type': 'DRUG', 'otherNames': ['Daklinza', 'Natdac', 'Daclahep', 'Dacihep', 'Hepdac', 'Mydekla'], 'description': 'Direct acting antiviral agent used for the treatment of hepatitis C', 'armGroupLabels': ['SOF+DAC+PEG', 'SOF+DAC, DOT', 'SOF+DAC, standard']}, {'name': 'Pegylated Interferon alfa-2a', 'type': 'DRUG', 'otherNames': ['Pegasys', 'Taspiance'], 'description': 'Antiviral agent used for the treatment of hepatitis C', 'armGroupLabels': ['SOF+DAC+PEG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '495009', 'city': 'Bilāspur', 'state': 'Chhattisgarh', 'country': 'India', 'facility': 'YR Gaitonde Centre for AIDS Education and Johns Hopkins University Collaborative Integrated Care Center (YRG-JHU ICC)', 'geoPoint': {'lat': 22.08005, 'lon': 82.15543}}], 'overallOfficials': [{'name': 'Shruti Mehta, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'YR Gaitonde Centre for AIDS Research and Education', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}