Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-03 @ 2:56 AM
Study NCT ID:
NCT02592057
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2015-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000069474', 'term': 'Sofosbuvir'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 532}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen', 'timeFrame': 'Up to Posttreatment Week 4'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12)', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 is defined as HCV RNA \\< the lower limit of quantification (LLOQ) 12 weeks following the last dose of study drug, respectively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical practice in India.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults residing in India aged ≥ 18 years, who are infected with HCV, and for whom the treating physicians in the participating clinics have prescribed a SOF-based regimen as per the approved prescribing information.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HCV-infected patients living in India\n* Treatment with a SOF-based regimen as determined by the patient's treating physician per the approved prescribing information.\n* Patients who provide written and signed informed consent prior to initiation of treatment where required.\n\nExclusion Criteria:\n\n* Concurrent participation in an HCV clinical trial (except trials not testing investigational medicinal products)\n* Patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country in a foreseeable future)"}, 'identificationModule': {'nctId': 'NCT02592057', 'briefTitle': 'Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Multicenter, Prospective, Observational, Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Patients With Chronic Hepatitis C Virus Infection in India', 'orgStudyIdInfo': {'id': 'GS-US-334-1775'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SOF-based regimens', 'description': 'Adults with chronic HCV infection in India who are being treated with a SOF-based treatment regimen as per the approved prescribing information.', 'interventionNames': ['Drug: SOF']}], 'interventions': [{'name': 'SOF', 'type': 'DRUG', 'otherNames': ['Sovaldi ®', 'GS-7977'], 'description': 'SOF tablets administered orally once daily based on approved prescribing information', 'armGroupLabels': ['SOF-based regimens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500 004', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Global Hospitals'}, {'zip': '110029', 'city': 'New Delhi', 'state': 'Ansari Nagar', 'country': 'India', 'facility': 'A.I.I.M.S.', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '395002', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'Nirmal Hospital Pvt. Ltd.', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '122001', 'city': 'Gurgaon', 'state': 'Haryana', 'country': 'India', 'facility': 'Artemis Hospital', 'geoPoint': {'lat': 28.4601, 'lon': 77.02635}}, {'zip': '560017', 'city': 'Bengaluru', 'state': 'Karnataka', 'country': 'India', 'facility': 'Manipal Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560098', 'city': 'Bengaluru', 'state': 'Karnataka', 'country': 'India', 'facility': 'BGS global Hospitals', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '682040', 'city': 'Kochi', 'state': 'Kerala', 'country': 'India', 'facility': 'Lakeshore Hospital', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'zip': '440 010', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Midas Institute of Gastro-enterology', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '302001', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'S.R. Kalla Memorial Gastro & General Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '302004', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'SMS Medical College & Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '302012', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Marudhar Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '600100', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Global Hospitals & Health City', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '641 005', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'VGM Hospital', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '226003', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'KGMU Medical College', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '160012', 'city': 'Chandigarh', 'state': 'Uttarakhand', 'country': 'India', 'facility': 'Postgraduate Institute of Medical Education and Research'}, {'zip': '700 020', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Institute of Post Graduate Medical Education And Research', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '380015', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Sanjivani Superspeciality Hospital Clinical Research Department', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380015', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Saviour Hospital', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '600116', 'city': 'Chennai', 'country': 'India', 'facility': 'Sri Ramachandra Medical College and Research', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '500035', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Aware Global Hospital', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '226003', 'city': 'Lucknow', 'country': 'India', 'facility': 'M.V. Hospital and Research Centre', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '226010', 'city': 'Lucknow', 'country': 'India', 'facility': 'K. R. M. Hospital & Research Centre', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '144001', 'city': 'Ludhiana', 'country': 'India', 'facility': 'Dayanand Medical College & Hospital', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}, {'zip': '400008', 'city': 'Mumbai', 'country': 'India', 'facility': 'BYL Nair Hospital & T N Medical College', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '110060', 'city': 'New Delhi', 'country': 'India', 'facility': 'Sir Ganga Ram Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '221007', 'city': 'Varanasi', 'country': 'India', 'facility': 'Om Research Center, Om Surgical Center & Maternity Home', 'geoPoint': {'lat': 25.31668, 'lon': 83.01041}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}