Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT03201718
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2017-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Viekira/Exviera for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 505}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)', 'timeFrame': '12 weeks after the last dose of study drug', 'description': 'the lower limit of quantitation (LLOQ) SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \\[\\<LLOQ\\]) 12 weeks after the last dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With On-treatment Virologic Failure', 'timeFrame': 'Up to 24 weeks', 'description': 'On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \\< LLOQ during treatment; confirmed increase of \\> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.'}, {'measure': 'Percentage of Participants With Post-treatment Relapse', 'timeFrame': 'From the end of treatment through 12 weeks after the last dose of study drug', 'description': 'Post-treatment relapse defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drugs among participants who complete treatment and with HCV RNA levels \\< LLOQ at the end of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis C', 'Paritaprevir', 'Ritonavir', 'Ombitasvir', 'Dasabuvir'], 'conditions': ['Hepatitis C Virus (HCV)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvie.com/content/dam/abbvie-dotcom/clinical-trials/ombitasvir_dasabuvir_P16-666.pdf', 'label': 'clinical study report synopsis'}]}, 'descriptionModule': {'briefSummary': 'Post-marketing surveillance study to evaluate the real world safety and effectiveness of Viekira/ Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) administered under a normal, routine treatment practice by Korean patients with Hepatitis C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Type C Hepatitis patients who had been prescribed Viekira/Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) in accordance with approved local label.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with type C hepatitis\n* Participants prescribed Viekira/Exviera in accordance with approved local label\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03201718', 'acronym': 'HCV PMS', 'briefTitle': 'A Study of Viekira/Exviera for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Post-marketing Surveillance Study of Viekira/ Exviera Tablets for Korean Hepatitis C Patients According to the Standard for "Re-examination of New Drugs"', 'orgStudyIdInfo': {'id': 'P16-666'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hepatitis C', 'description': 'Participants with Hepatitis C receiving Viekira/Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) for 12 or 24 weeks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49201', 'city': 'Busan', 'state': 'Busan Gwang Yeogsi', 'country': 'South Korea', 'facility': 'Dong-A University Hospital /ID# 167362', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '602-739', 'city': 'Busan', 'state': 'Busan Gwang Yeogsi', 'country': 'South Korea', 'facility': 'Pusan National University Hosp /ID# 167363', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '41944', 'city': 'Daegu', 'state': 'Daegu Gwang Yeogsi', 'country': 'South Korea', 'facility': 'Kyungpook National Univ Hosp /ID# 168731', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42415', 'city': 'Daegu', 'state': 'Daegu Gwang Yeogsi', 'country': 'South Korea', 'facility': 'Yeungnam University Med Ctr /ID# 167425', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '35015', 'city': 'Junggu', 'state': 'Daejeon Gwang Yeogsi', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital /ID# 167724', 'geoPoint': {'lat': 37.69175, 'lon': 126.60024}}, {'zip': '10444', 'city': 'Goyang', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'National health insurance cooperation ilsan hospital /ID# 201806', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'zip': '14584', 'city': 'Habun', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Bucheon /ID# 201803', 'geoPoint': {'lat': 34.67752, 'lon': 127.34834}}, {'zip': '13620', 'city': 'Seongnam', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'Seoul National Univ Bundang ho /ID# 167394', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '16247', 'city': 'Suwon', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': "St. Vincent's Hospital /ID# 201660", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'Ajou University Hospital /ID# 167729', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '47392', 'city': 'Pusan', 'state': 'Gyeongsangbuk-do', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital /ID# 167392', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'zip': '51394', 'city': 'Changwon', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Changwon Fatima Hospital /ID# 201664', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'zip': '22332', 'city': 'Junggu', 'state': 'Incheon Gwang Yeogsi', 'country': 'South Korea', 'facility': 'Inha University Hospital /ID# 201802', 'geoPoint': {'lat': 37.69175, 'lon': 126.60024}}, {'zip': '61469', 'city': 'Gwangju', 'state': 'Jeonranamdo', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital /ID# 167423', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '61661', 'city': 'Gwangju', 'state': 'Jeonranamdo', 'country': 'South Korea', 'facility': 'Kwangju Christian Hospital /ID# 210823', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '41404', 'city': 'Daegu', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Kyungpook National University Chilgok Hospital /ID# 201804', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '07061', 'city': 'Dongjak-gu', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'SMG-SNU Boramae Medical Center /ID# 201805'}, {'zip': '03181', 'city': 'Jongno-Gu', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital /ID# 168792'}, {'zip': '03722', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Severance Hospital /ID# 167361', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05030', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Konkuk University Medical Ctr /ID# 167723', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Samsung Medical Center /ID# 167722', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Korea Universtiy Guro Hospital /ID# 167388', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '420-818', 'city': 'Bucheon-si', 'country': 'South Korea', 'facility': "Bucheon St. Mary's hospital /ID# 170782", 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '46033', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dongnam Institute of Radiologi /ID# 167721', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '47007', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Good Samsun Hospital /ID# 167365', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48108', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Haeundae Paik Hospital /ID# 170767', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48972', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Maryknoll Medical Center /ID# 167418', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '602-702', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hosp /ID# 168797', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '630-723', 'city': 'Changwon', 'country': 'South Korea', 'facility': 'Samsung Changwon Hospital /ID# 167732', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'zip': '330-715', 'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Dankook University Hospital /ID# 167730', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'zip': '200-704', 'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Chuncheon Sacred Heart Hosp /ID# 167419', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '42488', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kim Jun Hwan Sok Internal Medi /ID# 168794', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '700-712', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung Univ Dongsan medical /ID# 168793', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '705-718', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Catholic University Med /ID# 167714', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '705-718', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Daegu Catholic University Med /ID# 168729', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '301-723', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'The Catholic Univ. of Korea /ID# 167733', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '410-773', 'city': 'Goyang', 'country': 'South Korea', 'facility': 'Dongguk University Ilsan Hosp /ID# 168795', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'zip': '412-270', 'city': 'Goyang', 'country': 'South Korea', 'facility': 'Myongji Hospital /ID# 170784', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'zip': '39295', 'city': 'Gumi', 'country': 'South Korea', 'facility': 'CHA Gumi Medical Center /ID# 170783', 'geoPoint': {'lat': 36.1136, 'lon': 128.336}}, {'zip': '152-703', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hosp /ID# 201661', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '18450', 'city': 'Hwaseong', 'country': 'South Korea', 'facility': 'Dongtan Sacred Heart Hospital /ID# 170759', 'geoPoint': {'lat': 35.24246, 'lon': 126.59882}}, {'zip': '21431', 'city': 'Incheon', 'country': 'South Korea', 'facility': "The Catholic University of Korea Incheon St.Mary's Hospital /ID# 170769", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '54987', 'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Presbyterian Medical Center /ID# 167424', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '463-712', 'city': 'Seongnam', 'country': 'South Korea', 'facility': 'CHA Bundang Medical Center /ID# 170757', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '463-824', 'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Bundang Jesaeng hospital /ID# 167725', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital /ID# 167731', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital /ID# 167364', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital /ID# 167389', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04401', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'SoonChunHyang University Seoul /ID# 167711', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center /ID# 167390', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06973', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hostipal /ID# 167420', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '100-032', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Inje University Seoul Paik Hos /ID# 167426', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Inje University Sanggye Paik H /ID# 167427', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '57931', 'city': 'Suncheon', 'country': 'South Korea', 'facility': 'St. Carollo General Hospital /ID# 167712', 'geoPoint': {'lat': 34.9505, 'lon': 127.48784}}, {'zip': '480-717', 'city': 'Uijeongbu-si', 'country': 'South Korea', 'facility': "Uijeongbu St. Mary's Hospital /ID# 168730", 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'zip': '682-714', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital /ID# 168796', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'zip': '220-701', 'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hosp /ID# 167713', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '50612', 'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yang /ID# 167710', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '59684', 'city': 'Yeosu', 'country': 'South Korea', 'facility': 'Yeosoo Hankook Hospital /ID# 168728', 'geoPoint': {'lat': 34.76062, 'lon': 127.66215}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}