Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-22 @ 11:43 AM
Study NCT ID:
NCT02480166
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2015-06-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C000595958', 'term': 'ledipasvir, sofosbuvir drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mindiehn@stanford.edu', 'phone': '650-4985691', 'title': 'Mindie H. Nguyen, MD, MAS', 'organization': 'Stanford University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Our population was small and our study was not powered to be able to determine significant differences between groups.'}}, 'adverseEventsModule': {'timeFrame': 'For each subject, AEs and SAEs are recorded after informed consent is obtained until 12 weeks post treatment.', 'description': "A Serious Adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 30 days of receiving the last dose of Study Product.\n\nAny serious adverse event that is ongoing when a subject completes his/her participation in the Study must be followed until the event resolves or stabilizes, returns baseline condition, or can be attributed to agents(s) other than the Study Product, or unrelated to Study conduct.", 'eventGroups': [{'id': 'EG000', 'title': '8 Weeks SOF/LED', 'description': "Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.\n\n8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '12 Weeks SOF/LED', 'description': "Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.\n\n12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.", 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 5, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Extended Treatment to 12 Weeks SOF/LED', 'description': "Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference", 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'notes': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Upper GI Bleed', 'notes': 'H.pylori-related bleeding gastric ulcer unrelated to study treatment. Subject achieved SVR 12.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical correction of left wrist fracture', 'notes': 'Surgical correction for wrist fracture due to a mechanical fall unrelated to study treatment. Subject achieved SVR 12.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '8 Weeks SOF/LED', 'description': "Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.\n\n8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."}, {'id': 'OG001', 'title': '12 Weeks SOF/LED', 'description': "Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.\n\n12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."}, {'id': 'OG002', 'title': 'Treatment Extension to 12 Weeks SOF/LED', 'description': "Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference"}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after end of therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '8 Weeks SOF/LED', 'description': "Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.\n\n8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."}, {'id': 'OG001', 'title': '12 Weeks SOF/LED', 'description': "Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.\n\n12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."}, {'id': 'OG002', 'title': 'Extended Treatment to 12 Weeks SOF/LED', 'description': "Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference"}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of treatment to 12 weeks post treatment', 'description': 'Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '8 Weeks SOF/LED', 'description': "Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.\n\n8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."}, {'id': 'FG001', 'title': '12 Weeks SOF/LED', 'description': "Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.\n\n12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."}, {'id': 'FG002', 'title': 'Extended Treatment to 12 Weeks SOF/LED', 'description': "Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '8 Weeks SOF/LED', 'description': "Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.\n\n8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."}, {'id': 'BG001', 'title': '12 Weeks SOF/LED', 'description': "Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.\n\n12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food."}, {'id': 'BG002', 'title': 'Extended Treatment to 12 Weeks SOF/LED', 'description': "Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference"}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '8', 'groupId': 'BG000'}, {'value': '60', 'spread': '12', 'groupId': 'BG001'}, {'value': '54', 'spread': '10', 'groupId': 'BG002'}, {'value': '59', 'spread': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Vietnamese', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}, {'title': 'Cambodian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Other Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '22.4', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '24.2', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '24.1', 'spread': '3.6', 'groupId': 'BG002'}, {'value': '23.6', 'spread': '3.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Comorbidities', 'classes': [{'title': 'Diabetes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Hyperlipidemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Coronary Artery Disease (CAD)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Chronic Obstructive Pulmonary Disease (COPD)', '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': 'HCV Genotype SubType', 'classes': [{'title': 'a/b', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'c-l', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'c', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Cirrhosis', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Decompensated Cirrhosis', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Decompensated cirrhosis is defined as presence/history of variceal bleeding, hepatic encephalopathy, or ascites at baseline.', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatocellular Carcinoma', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Treatment', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Proton Pump Inhibitor (PPI) usage', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'MELD, cirrhotics only', 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'BG000'}, {'value': '6.9', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}, {'value': '6.9', 'spread': '1.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The Model for End-Stage Liver Disease (MELD) Score uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. It is calculated according to the following formula: MELD = 3.78×ln\\[serum bilirubin (mg/dL)\\] + 11.2×ln\\[INR\\] + 9.57×ln\\[serum creatinine (mg/dL)\\] + 6.43. The total possible range for MELD scores is 6 (less ill) to 40 (gravely ill).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'log10 HCV RNA', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '7.2', 'spread': '0.3', 'groupId': 'BG002'}, {'value': '6.5', 'spread': '0.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 (IU/ml)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'White Blood Cell Count (WBC)', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '6.0', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '5.8', 'spread': '1.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'K/uL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '14.2', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '14.8', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '14.2', 'spread': '1.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Platelets', 'classes': [{'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000', 'lowerLimit': '186', 'upperLimit': '240'}, {'value': '181', 'groupId': 'BG001', 'lowerLimit': '133', 'upperLimit': '223'}, {'value': '201', 'groupId': 'BG002', 'lowerLimit': '189', 'upperLimit': '225'}, {'value': '201', 'groupId': 'BG003', 'lowerLimit': '151', 'upperLimit': '223'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'K/uL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '0.9', 'spread': '0.1', 'groupId': 'BG002'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'International Normalized Ratio (INR)', 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '1.0', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '1.0', 'spread': '0.0', 'groupId': 'BG002'}, {'value': '1.0', 'spread': '0.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The INR is based on the ratio of the patient's prothrombin time and the normal mean prothrombin time. The normal range for a healthy person who is not on anticoagulant therapy is 0.8-1.2, while higher values are targeted for people on anticoagulant therapy.", 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total bilirubin', 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '0.8', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '0.9', 'spread': '0.1', 'groupId': 'BG002'}, {'value': '0.7', 'spread': '0.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aspartate Aminotransferase (AST)', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '44'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '95'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '34'}, {'value': '39', 'groupId': 'BG003', 'lowerLimit': '29', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'description': 'AST is an enzyme that is secreted from the liver and can be found in liver, heart, muscle tissue, pancreas and kidneys. Elevated levels of AST may indicate inflammation or liver damage. Normal range for AST is typically 10-40 U/L.', 'unitOfMeasure': 'U/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Alanine Aminotransferase (ALT)', 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '59'}, {'value': '68', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '105'}, {'value': '33', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '41'}, {'value': '59', 'groupId': 'BG003', 'lowerLimit': '36', 'upperLimit': '76'}]}]}], 'paramType': 'MEDIAN', 'description': 'ALT is an enzyme that is secreted by the liver into the blood. Main storage of this enzyme is in the liver and elevated levels of ALT in the blood may indicate liver inflammation or damage. Normal range for ALT is typically between 7-56 U/L.', 'unitOfMeasure': 'U/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Albumin', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '4.0', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '1.5', 'groupId': 'BG002'}, {'value': '4.0', 'spread': '0.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-21', 'studyFirstSubmitDate': '2015-06-17', 'resultsFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2015-06-19', 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-21', 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment', 'timeFrame': '12 weeks after end of therapy'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.', 'timeFrame': 'Day 1 of treatment to 12 weeks post treatment', 'description': 'Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hepatitis C, genotype 6'], 'conditions': ['PT-NANBH']}, 'referencesModule': {'references': [{'pmid': '23944316', 'type': 'BACKGROUND', 'citation': 'Lawitz E, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 Aug 15;369(7):678-9. doi: 10.1056/NEJMc1307641. No abstract available.'}, {'pmid': '21038410', 'type': 'BACKGROUND', 'citation': 'Lam KD, Trinh HN, Do ST, Nguyen TT, Garcia RT, Nguyen T, Phan QQ, Nguyen HA, Nguyen KK, Nguyen LH, Nguyen MH. Randomized controlled trial of pegylated interferon-alfa 2a and ribavirin in treatment-naive chronic hepatitis C genotype 6. Hepatology. 2010 Nov;52(5):1573-80. doi: 10.1002/hep.23889.'}, {'pmid': '24725238', 'type': 'BACKGROUND', 'citation': 'Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93. doi: 10.1056/NEJMoa1316366. Epub 2014 Apr 11.'}, {'pmid': '24725239', 'type': 'BACKGROUND', 'citation': 'Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.'}, {'pmid': '21623850', 'type': 'BACKGROUND', 'citation': 'Chao DT, Abe K, Nguyen MH. Systematic review: epidemiology of hepatitis C genotype 6 and its management. Aliment Pharmacol Ther. 2011 Aug;34(3):286-96. doi: 10.1111/j.1365-2036.2011.04714.x. Epub 2011 May 29.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to describe the efficacy of:\n\n1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6\n2. 12-week treatment of SOF/LED for all other HCV-6 populations', 'detailedDescription': 'The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, age ≥18 years\n2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6\n3. Selected to start on treatment by their treating providers\n4. Willing and able to provide informed consent\n5. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments\n6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline\n7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception\n8. Lactating females must agree to discontinue nursing before the study drug is administered\n\nExclusion Criteria:\n\n1. Previous recipient of a liver transplant\n2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)'}, 'identificationModule': {'nctId': 'NCT02480166', 'briefTitle': 'Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparative Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir for 8 or 12 Weeks for Chronic Hepatitis C Genotype 6', 'orgStudyIdInfo': {'id': '33196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '8 weeks SOF/LED', 'description': 'Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.', 'interventionNames': ['Drug: 8 weeks SOF/LED']}, {'type': 'EXPERIMENTAL', 'label': '12 weeks SOF/LED', 'description': 'Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.', 'interventionNames': ['Drug: 12 weeks SOF/LED']}], 'interventions': [{'name': '8 weeks SOF/LED', 'type': 'DRUG', 'otherNames': ['Harvoni', 'Solvaldi'], 'description': "Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.", 'armGroupLabels': ['8 weeks SOF/LED']}, {'name': '12 weeks SOF/LED', 'type': 'DRUG', 'otherNames': ['Harvoni', 'Solvaldi'], 'description': "Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.", 'armGroupLabels': ['12 weeks SOF/LED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'San Jose Gastroenterology', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '77072', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Liver and Digestive Consultants', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Digestive Health Associates', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Mindie H Nguyen, MD, MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Mindie H. Nguyen', 'investigatorAffiliation': 'Stanford University'}}}}