A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-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
NCT ID: NCT03222583
Last Updated: 2019-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
546 participants
INTERVENTIONAL
2017-10-04
2019-02-15
Brief Summary
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Detailed Description
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All Primary and Secondary Outcome Measures were pre-specified to be analyzed only in Arm A.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Glecaprevir/Pibrentasvir
Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 or 16 weeks during the double-blind (DB) treatment period.
Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Placebo / Glecaprevir/Pibrentasvir
Participants received placebo to glecaprevir/pibrentasvir for 8 or 16 weeks during the DB treatment period followed by glecaprevir/pibrentasvir (300 mg/120 mg) once daily for 8 or 16 weeks during the open-label (OL) treatment period.
In each period participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Placebo
Matching placebo tablet for oral administration
Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Interventions
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Placebo
Matching placebo tablet for oral administration
Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5 or 6 infection.
* Positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) viral load ≥ 1000 IU/ mL at Screening Visit.
* Chronic HCV infection defined as one of the following:
* Positive for anti-HCV Ab or HCV RNA at least 6 months before Screening; or
* A liver biopsy consistent with chronic HCV infection
* 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.
* Participant must be documented as non-cirrhotic.
* Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection must also meet the following criteria:
* Positive test result for human immunodeficiency virus antibody (HIV Ab) at Screening
* Naïve to treatment with any antiretroviral therapy (ART) with a cluster of differentiation (CD)4+ count greater than or equal to 500 cells/mm³ (or CD4+ percent ≥ 29%)
* On a stable, qualifying HIV-1 ART regimen with CD4+ count ≥ 200 cells/mm³ (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.
Exclusion Criteria
* Any cause of liver disease other than chronic HCV-infection.
* HCV genotype performed during screening indicating co-infection with more than one HCV genotype
* Clinically significant abnormalities, other than HCV infection or HCV/HIV co-infection
* Chronic human immunodeficiency virus, type 2 (HIV-2) infection
* For participants on stable ART, taking anti-retroviral agent(s) other than those permitted
* 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
* Diagnosis of any clinical AIDS-defining event within 12 months prior to Screening.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Peking University Peoples Hospit /ID# 156846
Beijing, Beijing Municipality, China
Guangzhou Eighth People's Hosp /ID# 156859
Guangzhou, Guangdong, China
Guangdong General Hospital /ID# 156822
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 156860
Guangzhou, Guangdong, China
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156900
Guangzhou, Guangdong, China
Xiangya Hospital Central South University /ID# 156901
Changsha, Hunan, China
The Second Hospital of Nanjing /ID# 156863
Nanjing, Jiangsu, China
Jiangsu Province People's Hospital /ID# 156861
Nanjing, Jiangsu, China
The First Hosp of Jilin Univ /ID# 156820
Changchun, Jilin, China
The Sixth People's Hospital of Shenyang /ID# 156849
Shenyang, Liaoning, China
Shanghai Changzheng Hospital /ID# 158072
Shanghai, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiaotong /ID# 157336
Shanghai, Shanghai Municipality, China
Huashan Hospital of Fudan University /ID# 156904
Shanghai, Shanghai Municipality, China
Shanghai Public Health Cli Ctr /ID# 156832
Shanghai, Shanghai Municipality, China
West China Hospital /ID# 156830
Chengdu, Sichuan, China
Beijing Di Tan Hospital, Capital Medical University /ID# 156847
Beijing, , China
1st Hospital of Peking Uni /ID# 156845
Beijing, , China
302 Military Hospital Of China /ID# 156841
Beijing, , China
Beijing Friendship Hospital /ID# 156840
Beijing, , China
Beijing Youan Hosp, Cap Med Un /ID# 163430
Beijing, , China
1st Affiliated Hosp 3rd Milita /ID# 156831
Chongqing, , China
Dalian Sixth Peoples Hospital /ID# 163433
Dalian, , China
Mengchao Hepatobiliary Hospita /ID# 156902
Fuzhou, , China
Hainan General Hospital /ID# 156839
Haikou, Hainan, , China
Jinan Infectious Diseases Hosp /ID# 156886
Jinan, Shandong, , China
Chinese People's Liberation Army 81 Hospital /ID# 156862
Nanjing, , China
Shengjing Hospital of China Medical University /ID# 156824
Shenyang, , China
Tianjin Third Central Hospital /ID# 156816
Tianjin, , China
1st Aff Hosp Xinjiang Med Uni /ID# 156887
Ürümqi, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 156884
Wuhan, , China
Tongji Hosp Tongji Med College /ID# 156885
Wuhan, , China
Fourth Military Medical University Tangdu Hospital, PLA /ID# 156765
Xi'an, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163432
Xi'an, , China
Henan Provincial Peoples Hosp /ID# 157197
Zhengzhou, Henan, , China
National University Hospital ( /ID# 163272
Singapore, , Singapore
Singapore General Hospital /ID# 163271
Singapore, , Singapore
Changi General Hospital /ID# 163270
Singapore, , Singapore
Pusan National University Hosp /ID# 163371
Busan, Busan Gwang Yeogsi, South Korea
Seoul National Univ Bundang ho /ID# 163367
Seongnam, Gyeonggido, South Korea
Inje University Busan Paik Hospital /ID# 163329
Pusan, Gyeongsangbuk-do, South Korea
Pusan Nat Univ Yangsan Hosp /ID# 163334
Yangsan, Gyeongsangnam-do, South Korea
Inha University Hospital /ID# 163320
Junggu, Incheon Gwang Yeogsi, South Korea
Yonsei University Health System, Severance Hospital /ID# 163339
Seodaemun-gu, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 163364
Seoul, Seoul Teugbyeolsi, South Korea
Cath Univ Seoul St Mary's Hosp /ID# 163341
Seoul, Seoul Teugbyeolsi, South Korea
Korea Universtiy Guro Hospital /ID# 163380
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital /ID# 163348
Seoul, , South Korea
Asan Medical Center /ID# 163336
Seoul, , South Korea
Countries
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References
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Wei L, Wang G, Alami NN, Xie W, Heo J, Xie Q, Zhang M, Kim YJ, Lim SG, Fredrick LM, Lu W, Liu W, Kalluri HV, Krishnan P, Tripathi R, Mobashery N, Burroughs M, Asatryan A, Jia J, Hou J. Glecaprevir-pibrentasvir to treat chronic hepatitis C virus infection in Asia: two multicentre, phase 3 studies- a randomised, double-blind study (VOYAGE-1) and an open-label, single-arm study (VOYAGE-2). Lancet Gastroenterol Hepatol. 2020 Sep;5(9):839-849. doi: 10.1016/S2468-1253(20)30086-8. Epub 2020 Jul 16.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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M15-592
Identifier Type: -
Identifier Source: org_study_id