Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2026-03-24 @ 5:31 PM
Study NCT ID:
NCT02253550
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2014-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], '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': 'D000069616', 'term': 'Simeprevir'}, {'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': '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': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-22', 'studyFirstSubmitDate': '2014-09-17', 'studyFirstSubmitQcDate': '2014-09-27', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12)', 'timeFrame': '12 weeks post-treatment', 'description': 'HCV RNA will be measured 12 weeks post-treatment to evaluate SVR'}], 'secondaryOutcomes': [{'measure': 'Sustained Virologic Response 4 and 24 Weeks after Treatment Completion', 'timeFrame': '4 and 24 weeks post-treatment', 'description': 'HCV RNA will be measured 4 and 24 weeks post-treatment to evaluate SVR'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This study will look at the safety and efficacy of 8 week and 12 week treatment with Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic hepatitis C genotype 4.', 'detailedDescription': 'Patients with confirmed absence of cirrhosis will receive 8 weeks of treatment with Sofosbuvir and Simeprevir. Patients with confirmed presence of cirrhosis will receive 12 weeks of treatment with Sofosbuvir and Simeprevir. All patients will followed for 24 weeks post-treatment. Presence or absence of cirrhosis will be evaluated by FibroScan if no historical liver biopsy or FibroScan is available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HCV genotype 4 infection\n* HCV RNA \\>10,000 IU/mL at screening.\n\nExclusion Criteria:\n\n* Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy).\n* Any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator.\n* Infection/co-infection with HCV non-genotype 4.\n* Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening).\n* Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen \\[HBsAg\\] positive).\n* Presence of significant co-morbidities or conditions that would compromise the subject's safety and could interfere with the subject's participation for the full duration of the study in the opinion of the investigator\n* Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection."}, 'identificationModule': {'nctId': 'NCT02253550', 'briefTitle': 'Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection', 'organization': {'class': 'OTHER', 'fullName': 'Peter J. Ruane, M.D., Inc.'}, 'officialTitle': 'A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of an 8-Week and 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection With and Without Cirrhosis', 'orgStudyIdInfo': {'id': 'TMC435HPC2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cirrhosis', 'description': 'Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir', 'interventionNames': ['Drug: Simeprevir', 'Drug: Sofosbuvir']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Cirrhotic', 'description': 'Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir', 'interventionNames': ['Drug: Simeprevir', 'Drug: Sofosbuvir']}], 'interventions': [{'name': 'Simeprevir', 'type': 'DRUG', 'otherNames': ['Olysio; TMC435'], 'description': 'Simeprevir is a Hepatitis C Virus (HCV) NS3/4A protease inhibitor approved in the United States, Canada and Japan for the treatment of chronic HCV infection.', 'armGroupLabels': ['Cirrhosis', 'Non-Cirrhotic']}, {'name': 'Sofosbuvir', 'type': 'DRUG', 'otherNames': ['Sovaldi; GS-7977; PSI-7977'], 'description': 'Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.', 'armGroupLabels': ['Cirrhosis', 'Non-Cirrhotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Peter J. Ruane, MD, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Peter J Ruane, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peter J. Ruane, MD, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter J. Ruane, M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, President', 'investigatorFullName': 'Peter J. Ruane, M.D.', 'investigatorAffiliation': 'Peter J. Ruane, M.D., Inc.'}}}}