Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-02-25 @ 8:19 PM
Study NCT ID:
NCT02168361
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2014-06-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The SIM-SOF Trial for Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D005355', 'term': 'Fibrosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C417083', 'term': 'peginterferon alfa-2b'}, {'id': 'D000069616', 'term': 'Simeprevir'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'D000069474', 'term': 'Sofosbuvir'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': 'D009711', 'term': 'Nucleotides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brianpearlman3@hotmail.com', 'phone': '4042651044', 'title': 'Dr. Brian Pearlman', 'organization': 'Center for Hepatitis C'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Oral', 'otherNumAtRisk': 58, 'otherNumAffected': 46, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Interferon-containing', 'otherNumAtRisk': 24, 'otherNumAffected': 22, 'seriousNumAtRisk': 24, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Nervous system disorders'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 8}], 'organSystem': 'Nervous system disorders'}, {'term': 'asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'flu like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'neutropenia (500-750/mm3)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'high bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'high amylase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'liver decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With Sustained Virologic Response 12 (SVR-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Oral Therapy', 'description': 'Simeprevir-sofosbuvir'}, {'id': 'OG001', 'title': 'Interferon-containing Arm', 'description': 'Peginterferon/ribavirin/sofosbuvir'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.02', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Null hypothesis is no difference between two regimens in SVR-12.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks post-therapy', 'description': 'Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that received at least a single dose of medication'}, {'type': 'SECONDARY', 'title': 'Serum HCV RNA Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Oral Therapy', 'description': 'Simeprevir-sofosbuvir'}, {'id': 'OG001', 'title': 'Interferon-containing Arm', 'description': 'Peginterferon/ribavirin/sofosbuvir'}], 'classes': [{'title': 'Serum HCV RNA level at 4 weeks', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3000'}, {'value': '880', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8500'}]}]}, {'title': 'Serum HCV RNA level at 8 weeks', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '740', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6050'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 and 12 weeks into therapy', 'unitOfMeasure': 'IU/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants that received at least a single dose of medication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Oral Therapy', 'description': 'Simeprevir-sofosbuvir'}, {'id': 'FG001', 'title': 'Interferon-containing Arm', 'description': 'Peginterferon/ribavirin/sofosbuvir'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Therapy Arm'}, {'id': 'BG001', 'title': 'Interferon-containing Arm'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Younger than 18 years old', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '18 years or older', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants that received at least a single dose of medication'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-11', 'studyFirstSubmitDate': '2014-06-17', 'resultsFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2014-06-19', 'lastUpdatePostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-05', 'studyFirstPostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With Sustained Virologic Response 12 (SVR-12)', 'timeFrame': '12 weeks post-therapy', 'description': 'Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy'}], 'secondaryOutcomes': [{'measure': 'Serum HCV RNA Level', 'timeFrame': '4 and 12 weeks into therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cirrhosis'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '25557952', 'type': 'RESULT', 'citation': "Pearlman BL, Ehleben C, Perrys M. The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related Child's class A cirrhosis. Gastroenterology. 2015 Apr;148(4):762-70.e2; quiz e11-2. doi: 10.1053/j.gastro.2014.12.027. Epub 2014 Dec 31."}]}, 'descriptionModule': {'briefSummary': 'Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.', 'detailedDescription': "Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.\n\nMust have Child's Class A cirrhosis/compensated and no history of decompensation"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic hepatitis c,\n* cirrhosis biopsy-proven, or via fibrotest,\n* CPT score less than 7,\n* genotype 1a,\n* INR 2.3 or less,\n* serum albumin greater than 2.7 gm/dL,\n* total bilirubin less than 3 gm/dL,\n* platelet count 50,000 per cubic milliliter or more\n* GFR \\>50 ml/min\n\nExclusion Criteria:\n\n* non genotype 1a,\n* history of CPT class B or C or decompensation or history of same,\n* HIV or HBV coinfection,\n* prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent,\n* uncontrolled psychiatric or cardiopulmonary disorders,\n* planning pregnancy or unwilling/unable to practice contraception'}, 'identificationModule': {'nctId': 'NCT02168361', 'briefTitle': 'The SIM-SOF Trial for Hepatitis C', 'organization': {'class': 'OTHER', 'fullName': 'Center For Hepatitis C, Atlanta, GA'}, 'officialTitle': 'The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis', 'orgStudyIdInfo': {'id': 'CHC-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'description': 'Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks', 'interventionNames': ['Drug: Pegylated Interferon alfa-2b', 'Drug: Ribavirin', 'Drug: Sofosbuvir']}, {'type': 'EXPERIMENTAL', 'label': 'Simeprevir + Sofosbuvir', 'description': '(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks', 'interventionNames': ['Drug: Simeprevir', 'Drug: Sofosbuvir']}], 'interventions': [{'name': 'Pegylated Interferon alfa-2b', 'type': 'DRUG', 'otherNames': ['Pegintron'], 'description': '1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total', 'armGroupLabels': ['Standard']}, {'name': 'Simeprevir', 'type': 'DRUG', 'otherNames': ['Olysio'], 'description': '150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks', 'armGroupLabels': ['Simeprevir + Sofosbuvir']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Ribavirin Ribasphere Ribapak'], 'description': '1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir', 'armGroupLabels': ['Standard']}, {'name': 'Sofosbuvir', 'type': 'DRUG', 'otherNames': ['Sovaldi'], 'description': '12 weeks of combination sofosbuvir and simeprevir', 'armGroupLabels': ['Simeprevir + Sofosbuvir', 'Standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Center for Hepatitis C', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Brian L Pearlman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Hepatitis C'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center For Hepatitis C, Atlanta, GA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}