Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT02657694
Status:
UNKNOWN
Last Update Posted:
2017-02-16
First Post:
2016-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-05-13', 'releaseDate': '2019-02-13'}], 'estimatedResultsFirstSubmitDate': '2019-02-13'}}, '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'}, {'id': 'D016568', 'term': 'Drugs, Generic'}, {'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'C000611331', 'term': 'sofosbuvir-velpatasvir drug combination'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 'ESTIMATED', 'count': 10000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2016-01-14', 'studyFirstSubmitQcDate': '2016-01-14', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Virological Response 4 (SVR4) by Hepatitis C Virus (HVC) RNA Polymerase Chain Reaction (PCR)', 'timeFrame': '4-7 months', 'description': 'Viral load 4 weeks after cessation of treatment as measured by HCV RNA PCR, where SVR is defined as HCV RNA \\< Lower Limit Of Quantification (LLOQ)'}], 'secondaryOutcomes': [{'measure': 'Side Effects', 'timeFrame': '3-6 months', 'description': 'Collating common side effects on treatment'}, {'measure': 'Rapid Virological Response (RVR) by HCV RNA PCR', 'timeFrame': '4 weeks', 'description': 'Viral load 4 weeks after starting treatment as measured by HCV RNA PCR'}, {'measure': 'End Of Treatment (EOT) Response by HCV RNA PCR', 'timeFrame': '3-6 months', 'description': 'Viral load at end of treatment as measured by HCV RNA PCR'}, {'measure': 'Sustained Virological Response (SVR12) by HCV RNA PCR', 'timeFrame': '6-12 months', 'description': 'Viral load 12 weeks after cessation of treatment as measured by HCV RNA PCR, where SVR is defined as HCV RNA \\< Lower Limit Of Quantification (LLOQ)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://fixhepc.com', 'label': 'REDEMPTION Website'}]}, 'descriptionModule': {'briefSummary': 'REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is observing and collating the treatment course, safety profile, and outcomes of patients around the world who are choosing to self import generic versions of the Direct Acting Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.', 'detailedDescription': 'The high prices of Hepatitis C Virus (HCV) Direct Acting Antiviral (DAA) medications in many countries have led patients to seek out less expensive generic alternatives.\n\nThe efficacy and safety of these generic medications has not been formally demonstrated in clinical practice.\n\nThe primary goal of REDEMPTION is to collate the clinical results of these generic medications.\n\nThe secondary goal is to answer efficacy questions for which there is currently insufficient trial data available - for example Sofosbuvir+Daclatasvir appears to be an inexpensive pan genotypic solution to treat HCV globally but this is supported by a total n of less than 1000, and in some common genotypes, such as HCV Genotype 2, by an n of only 52 making for a wide margin of error and a high degree of uncertainty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Worldwide, Hepatitis C Genotypes 1-6', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nQuantitative HCV RNA \\> 100\n\nExclusion Criteria:\n\nContraindications to DAA medications'}, 'identificationModule': {'nctId': 'NCT02657694', 'acronym': 'REDEMPTION', 'briefTitle': 'Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods', 'organization': {'class': 'OTHER', 'fullName': 'FixHepC'}, 'officialTitle': 'Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods', 'orgStudyIdInfo': {'id': 'REDEMPTION'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sofosbuvir+Ledipasvir', 'description': 'Following patients treating with Sofosbuvir+Ledipasvir', 'interventionNames': ['Drug: Sofosbuvir+Ledipasvir']}, {'label': 'Sofosbuvir+Daclatasvir', 'description': 'Following patients treating with Sofosbuvir+Daclatasvir', 'interventionNames': ['Drug: Sofosbuvir+Daclatasvir']}, {'label': 'Sofosbuvir+Velpatasvir', 'description': 'Following patients treating with Sofosbuvir+Velpatasvir', 'interventionNames': ['Drug: Sofosbuvir+Velpatasvir']}], 'interventions': [{'name': 'Sofosbuvir+Ledipasvir', 'type': 'DRUG', 'otherNames': ['Harvoni (generic)'], 'description': 'DAA medication treatment', 'armGroupLabels': ['Sofosbuvir+Ledipasvir']}, {'name': 'Sofosbuvir+Daclatasvir', 'type': 'DRUG', 'otherNames': ['Sovaldi (generic)', 'Daklinza (generic)'], 'description': 'DAA medication treatment', 'armGroupLabels': ['Sofosbuvir+Daclatasvir']}, {'name': 'Sofosbuvir+Velpatasvir', 'type': 'DRUG', 'otherNames': ['Epclusa (generic)'], 'description': 'DAA medication treatment', 'armGroupLabels': ['Sofosbuvir+Velpatasvir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7004', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'FixHepC', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}], 'overallOfficials': [{'name': 'James Freeman, MB,BS,BSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ACRRM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FixHepC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-02-13', 'type': 'RELEASE'}, {'date': '2019-05-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'FixHepC'}}}}