Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection
VOYAGE-2
An Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection
1 other identifier
interventional
160
2 countries
34
Brief Summary
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with compensated cirrhosis with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon \[pegIFN\]) with or without ribavirin (RBV) OR sofosbuvir with RBV with or without IFN.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2017
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 1, 2017
CompletedStudy Start
First participant enrolled
September 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2019
CompletedResults Posted
Study results publicly available
November 21, 2019
CompletedNovember 21, 2019
August 1, 2019
1.1 years
July 28, 2017
November 4, 2019
November 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.
12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
Secondary Outcomes (3)
Percentage of Participants With On-treatment Virologic Failure
12 or 16 weeks depending on the treatment regimen
Percentage of Participants With Post-treatment Relapse
From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).
Percentage of HCV/HIV Co-infected Participants Achieving SVR12
12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen
Study Arms (1)
Glecaprevir/Pibrentasvir
EXPERIMENTALParticipants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Interventions
Coformulated tablet for oral administration
Eligibility Criteria
You may qualify if:
- Must be of Asian descent.
- 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) greater than or equal to 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 (RBV) OR sofosbuvir with RBV with or without IFN. Previous treatment must have been completed \>= 8 weeks prior to screening.
- Compensated cirrhosis defined as Child-Pugh score of ≤ 6 at Screening and no current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites noted on physical exam, bleeding varices, use of diuretics for ascites, or hepatic encephalopathy.
- Absence of hepatocellular carcinoma (HCC)
- 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+ % \>= 29%), or
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (34)
Peking University Peoples Hospit /ID# 156851
Beijing, Beijing Municipality, 100044, China
Guangzhou Eighth People's Hosp /ID# 156865
Guangzhou, Guangdong, 510060, China
Guangdong General Hospital /ID# 156827
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University /ID# 156866
Guangzhou, Guangdong, 510515, China
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156905
Guangzhou, Guangdong, 510630, China
The Second Hospital of Nanjing /ID# 156869
Nanjing, Jiangsu, 210003, China
Jiangsu Province People's Hospital /ID# 156867
Nanjing, Jiangsu, 210029, China
The First Hosp of Jilin Univ /ID# 156825
Changchun, Jilin, 130021, China
The Sixth People's Hospital of Shenyang /ID# 156854
Shenyang, Liaoning, 110006, China
Ruijin Hospital, Shanghai Jiaotong /ID# 157337
Shanghai, Shanghai Municipality, 200025, China
Huashan Hospital of Fudan University /ID# 156909
Shanghai, Shanghai Municipality, 200040, China
Shanghai Public Health Cli Ctr /ID# 156837
Shanghai, Shanghai Municipality, 201508, China
West China Hospital /ID# 156835
Chengdu, Sichuan, 610041, China
Beijing Di Tan Hospital, Capital Medical University /ID# 156852
Beijing, 100015, China
1st Hospital of Peking Uni /ID# 156850
Beijing, 100034, China
Beijing Friendship Hospital /ID# 156843
Beijing, 100050, China
Beijing Youan Hosp, Cap Med Un /ID# 163418
Beijing, 100069, China
2nd Affiliated Hosp Chongqing /ID# 156838
Chongqing, 400010, China
Mengchao Hepatobiliary Hospita /ID# 156907
Fuzhou, 350025, China
Chinese People's Liberation Army 81 Hospital /ID# 156868
Nanjing, 210002, China
Shengjing Hospital of China Medical University /ID# 156829
Shenyang, 110004, China
1st Aff Hosp Xinjiang Med Uni /ID# 156891
Ürümqi, 830054, China
Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767
Xi'an, 710038, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163420
Xi'an, 710061, China
Henan Provincial Peoples Hosp /ID# 157371
Zhengzhou, Henan, 450000, China
Pusan National University Hosp /ID# 163411
Busan, Busan Gwang Yeogsi, 602-739, South Korea
Seoul National Univ Bundang ho /ID# 163408
Seongnam, Gyeonggido, 13620, South Korea
Inje University Busan Paik Hospital /ID# 163384
Pusan, Gyeongsangbuk-do, 47392, South Korea
Pusan Nat Univ Yangsan Hosp /ID# 163385
Yangsan, Gyeongsangnam-do, 50612, South Korea
Severance Hospital /ID# 163399
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Samsung Medical Center /ID# 163402
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Korea University Guro Hospital /ID# 163412
Seoul, Seoul Teugbyeolsi, 08308, South Korea
Seoul National University Hospital /ID# 163401
Seoul, 03080, South Korea
Asan Medical Center /ID# 163398
Seoul, 05505, South Korea
Related Publications (1)
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.
PMID: 32682494DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2017
First Posted
August 1, 2017
Study Start
September 29, 2017
Primary Completion
November 15, 2018
Study Completion
February 25, 2019
Last Updated
November 21, 2019
Results First Posted
November 21, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.