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16 weeks during the double-blind (DB) treatment period.\n\nParticipants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.",[13],"Drug: Glecaprevir\u002FPibrentasvir",{"label":15,"type":10,"description":16,"interventionNames":17},"Placebo \u002F Glecaprevir\u002FPibrentasvir","Participants received placebo to glecaprevir\u002Fpibrentasvir for 8 or 16 weeks during the DB treatment period followed by glecaprevir\u002Fpibrentasvir (300 mg\u002F120 mg) once daily for 8 or 16 weeks during the open-label (OL) treatment period.\n\nIn each period participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.",[18,13],"Drug: Placebo",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Placebo","Matching placebo tablet for oral 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156859","Guangzhou","Guangdong","510060",{"type":45,"coordinates":56},[57,58],113.25,23.11667,{"lat":58,"lon":57},{"facility":61,"status":25,"city":52,"state":53,"zip":62,"country":42,"countryCode":43,"cosmosGeoPoint":63,"geoPoint":65,"contacts":25},"Guangdong General Hospital \u002FID# 156822","510080",{"type":45,"coordinates":64},[57,58],{"lat":58,"lon":57},{"facility":67,"status":25,"city":52,"state":53,"zip":68,"country":42,"countryCode":43,"cosmosGeoPoint":69,"geoPoint":71,"contacts":25},"Nanfang Hospital of Southern Medical University \u002FID# 156860","510515",{"type":45,"coordinates":70},[57,58],{"lat":58,"lon":57},{"facility":73,"status":25,"city":52,"state":53,"zip":74,"country":42,"countryCode":43,"cosmosGeoPoint":75,"geoPoint":77,"contacts":25},"The Third Affiliated Hospital Of Sun Yat-Sen University \u002FID# 156900","510630",{"type":45,"coordinates":76},[57,58],{"lat":58,"lon":57},{"facility":79,"status":25,"city":80,"state":81,"zip":82,"country":42,"countryCode":43,"cosmosGeoPoint":83,"geoPoint":87,"contacts":25},"Xiangya Hospital Central South University \u002FID# 156901","Changsha","Hunan","410008",{"type":45,"coordinates":84},[85,86],112.97087,28.19874,{"lat":86,"lon":85},{"facility":89,"status":25,"city":90,"state":91,"zip":92,"country":42,"countryCode":43,"cosmosGeoPoint":93,"geoPoint":97,"contacts":25},"The Second Hospital of Nanjing \u002FID# 156863","Nanjing","Jiangsu","210003",{"type":45,"coordinates":94},[95,96],118.77778,32.06167,{"lat":96,"lon":95},{"facility":99,"status":25,"city":90,"state":91,"zip":100,"country":42,"countryCode":43,"cosmosGeoPoint":101,"geoPoint":103,"contacts":25},"Jiangsu Province People's Hospital \u002FID# 156861","210029",{"type":45,"coordinates":102},[95,96],{"lat":96,"lon":95},{"facility":105,"status":25,"city":106,"state":107,"zip":108,"country":42,"countryCode":43,"cosmosGeoPoint":109,"geoPoint":113,"contacts":25},"The First Hosp of Jilin Univ \u002FID# 156820","Changchun","Jilin","130021",{"type":45,"coordinates":110},[111,112],125.32278,43.88,{"lat":112,"lon":111},{"facility":115,"status":25,"city":116,"state":117,"zip":118,"country":42,"countryCode":43,"cosmosGeoPoint":119,"geoPoint":123,"contacts":25},"The Sixth People's Hospital of Shenyang \u002FID# 156849","Shenyang","Liaoning","110006",{"type":45,"coordinates":120},[121,122],123.43278,41.79222,{"lat":122,"lon":121},{"facility":125,"status":25,"city":126,"state":127,"zip":128,"country":42,"countryCode":43,"cosmosGeoPoint":129,"geoPoint":133,"contacts":25},"Shanghai Changzheng Hospital \u002FID# 158072","Shanghai","Shanghai Municipality","200003",{"type":45,"coordinates":130},[131,132],121.45806,31.22222,{"lat":132,"lon":131},{"facility":135,"status":25,"city":126,"state":127,"zip":136,"country":42,"countryCode":43,"cosmosGeoPoint":137,"geoPoint":139,"contacts":25},"Ruijin Hospital, Shanghai Jiaotong \u002FID# 157336","200025",{"type":45,"coordinates":138},[131,132],{"lat":132,"lon":131},{"facility":141,"status":25,"city":126,"state":127,"zip":142,"country":42,"countryCode":43,"cosmosGeoPoint":143,"geoPoint":145,"contacts":25},"Huashan Hospital of Fudan University \u002FID# 156904","200040",{"type":45,"coordinates":144},[131,132],{"lat":132,"lon":131},{"facility":147,"status":25,"city":126,"state":127,"zip":148,"country":42,"countryCode":43,"cosmosGeoPoint":149,"geoPoint":151,"contacts":25},"Shanghai Public Health Cli Ctr \u002FID# 156832","201508",{"type":45,"coordinates":150},[131,132],{"lat":132,"lon":131},{"facility":153,"status":25,"city":154,"state":155,"zip":156,"country":42,"countryCode":43,"cosmosGeoPoint":157,"geoPoint":161,"contacts":25},"West China Hospital \u002FID# 156830","Chengdu","Sichuan","610041",{"type":45,"coordinates":158},[159,160],104.06667,30.66667,{"lat":160,"lon":159},{"facility":163,"status":25,"city":39,"state":25,"zip":164,"country":42,"countryCode":43,"cosmosGeoPoint":165,"geoPoint":167,"contacts":25},"Beijing Di Tan Hospital, Capital Medical University \u002FID# 156847","100015",{"type":45,"coordinates":166},[47,48],{"lat":48,"lon":47},{"facility":169,"status":25,"city":39,"state":25,"zip":170,"country":42,"countryCode":43,"cosmosGeoPoint":171,"geoPoint":173,"contacts":25},"1st Hospital of Peking Uni \u002FID# 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156816","Tianjin","300170",{"type":45,"coordinates":244},[245,246],117.17667,39.14222,{"lat":246,"lon":245},{"facility":249,"status":25,"city":250,"state":25,"zip":251,"country":42,"countryCode":43,"cosmosGeoPoint":252,"geoPoint":256,"contacts":25},"1st Aff Hosp Xinjiang Med Uni \u002FID# 156887","Ürümqi","830054",{"type":45,"coordinates":253},[254,255],87.60046,43.80096,{"lat":255,"lon":254},{"facility":258,"status":25,"city":259,"state":25,"zip":260,"country":42,"countryCode":43,"cosmosGeoPoint":261,"geoPoint":265,"contacts":25},"Union Hospital Tongji Medical College Huazhong University of Science and Technol \u002FID# 156884","Wuhan","430022",{"type":45,"coordinates":262},[263,264],114.26667,30.58333,{"lat":264,"lon":263},{"facility":267,"status":25,"city":259,"state":25,"zip":268,"country":42,"countryCode":43,"cosmosGeoPoint":269,"geoPoint":271,"contacts":25},"Tongji Hosp Tongji Med College \u002FID# 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Henan","450000",{"facility":292,"status":25,"city":293,"state":25,"zip":294,"country":293,"countryCode":295,"cosmosGeoPoint":296,"geoPoint":300,"contacts":25},"National University Hospital ( \u002FID# 163272","Singapore","119228","SG",{"type":45,"coordinates":297},[298,299],103.85007,1.28967,{"lat":299,"lon":298},{"facility":302,"status":25,"city":293,"state":25,"zip":303,"country":293,"countryCode":295,"cosmosGeoPoint":304,"geoPoint":306,"contacts":25},"Singapore General Hospital \u002FID# 163271","169608",{"type":45,"coordinates":305},[298,299],{"lat":299,"lon":298},{"facility":308,"status":25,"city":293,"state":25,"zip":309,"country":293,"countryCode":295,"cosmosGeoPoint":310,"geoPoint":312,"contacts":25},"Changi General Hospital \u002FID# 163270","529889",{"type":45,"coordinates":311},[298,299],{"lat":299,"lon":298},{"facility":314,"status":25,"city":315,"state":316,"zip":317,"country":318,"countryCode":25,"cosmosGeoPoint":319,"geoPoint":323,"contacts":25},"Pusan National University Hosp \u002FID# 163371","Busan","Busan Gwang Yeogsi","602-739","South Korea",{"type":45,"coordinates":320},[321,322],129.03004,35.10168,{"lat":322,"lon":321},{"facility":325,"status":25,"city":326,"state":327,"zip":328,"country":318,"countryCode":25,"cosmosGeoPoint":329,"geoPoint":333,"contacts":25},"Seoul National Univ Bundang ho \u002FID# 163367","Seongnam","Gyeonggido","13620",{"type":45,"coordinates":330},[331,332],127.7548,36.4052,{"lat":332,"lon":331},{"facility":335,"status":25,"city":336,"state":337,"zip":338,"country":318,"countryCode":25,"cosmosGeoPoint":339,"geoPoint":343,"contacts":25},"Inje University Busan Paik Hospital \u002FID# 163329","Pusan","Gyeongsangbuk-do","47392",{"type":45,"coordinates":340},[341,342],128.3681,36.3809,{"lat":342,"lon":341},{"facility":345,"status":25,"city":346,"state":347,"zip":348,"country":318,"countryCode":25,"cosmosGeoPoint":349,"geoPoint":353,"contacts":25},"Pusan Nat Univ Yangsan Hosp \u002FID# 163334","Yangsan","Gyeongsangnam-do","50612",{"type":45,"coordinates":350},[351,352],129.03358,35.34199,{"lat":352,"lon":351},{"facility":355,"status":25,"city":356,"state":357,"zip":358,"country":318,"countryCode":25,"cosmosGeoPoint":359,"geoPoint":363,"contacts":25},"Inha University Hospital \u002FID# 163320","Junggu","Incheon Gwang Yeogsi","22332",{"type":45,"coordinates":360},[361,362],126.60024,37.69175,{"lat":362,"lon":361},{"facility":365,"status":25,"city":366,"state":367,"zip":368,"country":318,"countryCode":25,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Yonsei University Health System, Severance Hospital \u002FID# 163339","Seodaemun-gu","Seoul Teugbyeolsi","03722",{"facility":370,"status":25,"city":371,"state":367,"zip":372,"country":318,"countryCode":25,"cosmosGeoPoint":373,"geoPoint":377,"contacts":25},"Samsung Medical Center \u002FID# 163364","Seoul","06351",{"type":45,"coordinates":374},[375,376],126.9784,37.566,{"lat":376,"lon":375},{"facility":379,"status":25,"city":371,"state":367,"zip":380,"country":318,"countryCode":25,"cosmosGeoPoint":381,"geoPoint":383,"contacts":25},"Cath Univ Seoul St Mary's Hosp \u002FID# 163341","06591",{"type":45,"coordinates":382},[375,376],{"lat":376,"lon":375},{"facility":385,"status":25,"city":371,"state":367,"zip":386,"country":318,"countryCode":25,"cosmosGeoPoint":387,"geoPoint":389,"contacts":25},"Korea Universtiy Guro Hospital \u002FID# 163380","08308",{"type":45,"coordinates":388},[375,376],{"lat":376,"lon":375},{"facility":391,"status":25,"city":371,"state":25,"zip":392,"country":318,"countryCode":25,"cosmosGeoPoint":393,"geoPoint":395,"contacts":25},"Seoul National University Hospital \u002FID# 163348","03080",{"type":45,"coordinates":394},[375,376],{"lat":376,"lon":375},{"facility":397,"status":25,"city":371,"state":25,"zip":398,"country":318,"countryCode":25,"cosmosGeoPoint":399,"geoPoint":401,"contacts":25},"Asan Medical Center \u002FID# 163336","05505",{"type":45,"coordinates":400},[375,376],{"lat":376,"lon":375},{"type":403,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100302855","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-glecaprevirpibrentasvir-abt-493abt-530-in-treatment-naive-and-treatment-experienced-non-cirrhotic-asian-adults-with-chronic-hepatitis-c-virus-genotype-gt-1-to-gt6-infection-with-or-without-human-immunodeficiency-virus-co-infection-100302855",true,"NCT03222583","A Study to Evaluate the Efficacy and Safety of Glecaprevir\u002FPibrentasvir (ABT-493\u002FABT-530) in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection","A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493\u002FABT-530 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection","VOYAGE-1","Inclusion Criteria:\n\n* Must be of Asian descent\n* Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5 or 6 infection.\n* Positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) viral load ≥ 1000 IU\u002F mL at Screening Visit.\n* Chronic HCV infection defined as one of the following:\n\n  * Positive for anti-HCV Ab or HCV RNA at least 6 months before Screening; or\n  * A liver biopsy consistent with chronic HCV infection\n* HCV treatment-naïve to any approved or investigational HCV treatment or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon\\[pegIFN\\] with or without ribavirin, OR sofosbuvir with RBV with or without IFN. Previous treatment must have been completed ≥ 8 weeks prior to screening.\n* Participant must be documented as non-cirrhotic.\n* Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection must also meet the following criteria:\n\n  * Positive test result for human immunodeficiency virus antibody (HIV Ab) at Screening\n  * Naïve to treatment with any antiretroviral therapy (ART) with a cluster of differentiation (CD)4+ count greater than or equal to 500 cells\u002Fmm³ (or CD4+ percent ≥ 29%)\n  * On a stable, qualifying HIV-1 ART regimen with CD4+ count ≥ 200 cells\u002Fmm³ (or CD4+ % ≥ 14%) at Screening and plasma HIV-1 RNA below lower limit of quantification (LLOQ) by an approved plasma HIV-1 RNA quantitative assay at Screening and at least once during the 12 months prior to Screening.\n\nExclusion Criteria:\n\n* Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) if HBsAg is negative.\n* Any cause of liver disease other than chronic HCV-infection.\n* HCV genotype performed during screening indicating co-infection with more than one HCV genotype\n* Clinically significant abnormalities, other than HCV infection or HCV\u002FHIV co-infection\n* Chronic human immunodeficiency virus, type 2 (HIV-2) infection\n\nAdditional Exclusion Criteria for participants with HCV\u002FHIV Co-Infection:\n\n* For participants on stable ART, taking anti-retroviral agent(s) other than those permitted\n* Treatment for an acquired immunodeficiency syndrome (AIDS)-associated opportunistic infection within 12 months of Screening or prophylaxis for an AIDS-associated opportunistic infection within 6 months of screening\n* Diagnosis of any clinical AIDS-defining event within 12 months prior to Screening.",false,"ALL","18 Years",{"count":416,"type":417},546,"ACTUAL","INTERVENTIONAL",[420],"PHASE3","This study will evaluate the efficacy and safety of glecaprevir\u002Fpibrentasvir (ABT-493\u002FABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.",[423],"Hepatitis C Virus (HCV)",[425,426,427,428,429,430,431,432,433],"Chronic Hepatitis C Virus (HCV)","Genotype 1 to 6","Asian","non-cirrhotic","Human Immunodeficiency Virus","co-infection","Treatment-naïve","Treatment-experienced","interferon","COMPLETED","2019-12-05",{"date":437,"type":417},"2019-12-23",{"date":439,"type":417},"2017-10-04",{"date":441,"type":417},"2019-02-15",{"name":5,"class":6},48]