Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-02 @ 4:54 PM
Study NCT ID:
NCT02581020
Status:
COMPLETED
Last Update Posted:
2021-12-08
First Post:
2015-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-06', 'studyFirstSubmitDate': '2015-10-19', 'studyFirstSubmitQcDate': '2015-10-19', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatitis C virus ribonucleic acid (HCV RNA) levels', 'timeFrame': '60 months after completion of the 2D treatment in M12-536 or M13-004 study', 'description': 'HCV RNA levels in plasma'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3)', 'timeFrame': 'For approximately 5 years'}, {'measure': 'Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A)', 'timeFrame': 'For approximately 5 years'}, {'measure': 'Percentage of participants with hepatocellular carcinoma', 'timeFrame': 'Up to 60 month after completion of the 2D treatment in M12-536 or M13-004'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study', 'description': 'All serious adverse events will be monitored during the observation period.'}, {'measure': 'Hepatitis C virus ribonucleic acid (HCV RNA) levels', 'timeFrame': '18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study', 'description': 'HCV RNA levels in plasma'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis C', 'Follow-up', 'Observation', 'Japanese'], 'conditions': ['Hepatitis C Virus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.abbvie.com/content/dam/abbvie-dotcom/us/clinical-trials/ombitasvir_P15-349.pdf', 'label': 'clinical study report synopsis'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment of chronic hepatitis C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who were treated in Study M12-536 or M13-004 with 2D regimen (ombitasvir/ paritaprevir/ritonavir) and completed 48 weeks of follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants treated in Study M12-536 or M13-004 with the 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow-up, regardless of SVR achievement.\n* Participants who agree to sign the informed consent\n\nExclusion Criteria:\n\n* Participants treated with a direct-acting antiviral agent (DAA) immediately after Study M12-536 or M13-004.'}, 'identificationModule': {'nctId': 'NCT02581020', 'briefTitle': "The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects", 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': "A Follow-up Study to Assess the Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection", 'orgStudyIdInfo': {'id': 'P15-349'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Participants who were treated with 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow up from the prior Phase 2 or 3 studies conducted in Japan.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '467-8602', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya City University Hospital /ID# 157439', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '790-8524', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Matsuyama Red Cross Hospital /ID# 152125', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '810-8563', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'National Hospital Organization Kyushu Medical Center /ID# 161759', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '814-0180', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka University Hospital /ID# 155965', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '830-0011', 'city': 'Kurume-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kurume University Hospital /ID# 152123'}, {'zip': '503-8502', 'city': 'Ogaki-shi', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Ogaki Municipal Hospital /ID# 158105'}, {'zip': '371-8511', 'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Gunma University Hospital /ID# 158118', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '370-0829', 'city': 'Takasaki-shi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'National Hospital Organization Takasaki General Medical Center /ID# 152128'}, {'zip': '730-8619', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 152178', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '734-8551', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University Hospital /ID# 152232', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '080-0024', 'city': 'Obihiro-shi', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Obihiro kosei Hospital /ID# 157437'}, {'zip': '060-0033', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 153019', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '317-0077', 'city': 'Hitachi-shi', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Hitachi General Hospital /ID# 160800'}, {'zip': '920-8641', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Duplicate_Kanazawa University Hospital /ID# 152226', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '761-0793', 'city': 'Kita-gun', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Kagawa University Hospital /ID# 153548'}, {'zip': '232-0024', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Duplicate_Yokohama City University Medical Center /ID# 159474', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '236-0004', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama City University Hospital /ID# 165252', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '8628655', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto Shinto General Hospital /ID# 150061', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '700-8558', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Okayama University Hospital /ID# 150060', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '534-0021', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka City General Hospital /ID# 152126', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '543-8555', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Japanese Red Cross Osaka Hospital /ID# 155964', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '849-8501', 'city': 'Saga', 'state': 'Saga-ken', 'country': 'Japan', 'facility': 'Saga University Hospital /ID# 161757', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'zip': '350-0451', 'city': 'Iruma-gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University Hospital /ID# 153544'}, {'zip': '431-3192', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Hamamatsu University Hospital /ID# 152176', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '321-0293', 'city': 'Shimotsuga-gun', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'Dokkyo Medical University Hospital /ID# 152225'}, {'zip': '329-0498', 'city': 'Shimotsuke-shi', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'Jichi Medical University Hospital /ID# 153018'}, {'zip': '113-8431', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Juntendo University Hospital /ID# 153545'}, {'zip': '113-8655', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'The University of Tokyo Hospital /ID# 158121'}, {'zip': '105-8470', 'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Toranomon Hospital /ID# 152124'}, {'zip': '108-8642', 'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kitasato University Kitasato Institute Hospital /ID# 152145'}, {'zip': '930-8550', 'city': 'Toyama', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Toyama Prefectural Central Hospital /ID# 164156', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'zip': '755-8505', 'city': 'Ube-shi', 'state': 'Yamaguchi', 'country': 'Japan', 'facility': 'Yamaguchi University Hospital /ID# 166899'}, {'zip': '409-3821', 'city': 'Chuo-shi', 'state': 'Yamanashi', 'country': 'Japan', 'facility': 'University of Yamanashi Hospital /ID# 153547'}, {'zip': '838-0069', 'city': 'Asakura', 'country': 'Japan', 'facility': 'Asakura Medical Association Ho /ID# 155963', 'geoPoint': {'lat': 33.41439, 'lon': 130.71877}}, {'zip': '918-8235', 'city': 'Fukui', 'country': 'Japan', 'facility': 'Fukuiken Saiseikai Hospital /ID# 162898', 'geoPoint': {'lat': 34.84214, 'lon': 135.54836}}, {'zip': '500-8323', 'city': 'Gifu', 'country': 'Japan', 'facility': 'Gifu Municipal Hospital /ID# 152227', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '500-8727', 'city': 'Gifu', 'country': 'Japan', 'facility': 'Gifu Prefectural Genl Med Ctr /ID# 154796', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '563-8510', 'city': 'Ikeda', 'country': 'Japan', 'facility': 'Ikeda Municipal Hospital /ID# 150062', 'geoPoint': {'lat': 34.82208, 'lon': 135.4298}}, {'zip': '300-0332', 'city': 'Inashiki', 'country': 'Japan', 'facility': 'Tokyo Med Uni Ibaraki Med Ctr /ID# 152127', 'geoPoint': {'lat': 35.95633, 'lon': 140.32356}}, {'zip': '270-1613', 'city': 'Inzai', 'country': 'Japan', 'facility': 'Nippon Med Chiba Hokusoh Hosp /ID# 164155', 'geoPoint': {'lat': 35.83479, 'lon': 140.16361}}, {'zip': '890-8520', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Kagoshima Uni Med and Dental /ID# 157438', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '213-8587', 'city': 'Kawasaki', 'country': 'Japan', 'facility': 'Toranomon Hospital Kajigaya /ID# 152129', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '214-0021', 'city': 'Kawasaki', 'country': 'Japan', 'facility': 'Kawasaki Municipal Tama Hospit /ID# 153546', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '790-0024', 'city': 'Matsuyama', 'country': 'Japan', 'facility': 'Ehime Prefectural Central Hosp /ID# 158106', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '700-0821', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Kawasaki Hosp, Kawasaki Med /ID# 152180', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '572-0854', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Hospital /ID# 152177', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '338-8553', 'city': 'Saitama', 'country': 'Japan', 'facility': 'Japanese Red Cross Saitama Hos /ID# 166898', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '564-0013', 'city': 'Suita', 'country': 'Japan', 'facility': 'Saiseikai Suita Hospital /ID# 153549', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '760-0065', 'city': 'Takamatsu', 'country': 'Japan', 'facility': 'Kagawa Prefectural Central Hos /ID# 152179', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'zip': '646-8558', 'city': 'Tanabe', 'country': 'Japan', 'facility': 'Nat Hosp Org Minami Wakayama /ID# 153550', 'geoPoint': {'lat': 33.73333, 'lon': 135.36667}}, {'zip': '140-8522', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Toshiba General Hospital /ID# 152122', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '180-8610', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'JP Red Cross Musashino Hosp /ID# 152175', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '879-5503', 'city': 'Yufu-shi', 'country': 'Japan', 'facility': 'Oita University Hospital /ID# 165274'}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}