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
VOYAGE-1
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-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
1 other identifier
interventional
546
3 countries
48
Brief Summary
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2017
48 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 17, 2017
CompletedFirst Posted
Study publicly available on registry
July 19, 2017
CompletedStudy Start
First participant enrolled
October 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2019
CompletedResults Posted
Study results publicly available
December 23, 2019
CompletedDecember 23, 2019
November 1, 2019
1 year
July 17, 2017
October 16, 2019
December 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Sustained virologic response 12 weeks post-treatment (SVR12) was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug.
12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
Percentage of HCV GT1-Infected Participants in Arm A Who Achieved SVR12
SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug.
12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen
Percentage of HCV GT2-Infected Participants in Arm A Who Achieved SVR12
SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last actual dose of study drug.
12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
Secondary Outcomes (3)
Percentage of Participants in Arm A With On-treatment Virologic Failure
8 or 16 weeks depending on the treatment regimen
Percentage of Participants in Arm A With Post-treatment Relapse
From the end of treatment (Weeks 8 or 16) through 12 weeks after the last dose of study drug (Weeks 20 or 28 depending on the treatment regimen).
Percentage of HCV/HIV Co-infected Participants in Arm A Who Achieved SVR12
12 weeks after the last actual dose of study drug, Week 20 or 28 depending on the treatment regimen
Study Arms (2)
Glecaprevir/Pibrentasvir
EXPERIMENTALParticipants 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.
Placebo / Glecaprevir/Pibrentasvir
EXPERIMENTALParticipants 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.
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) 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.
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 (48)
Peking University Peoples Hospit /ID# 156846
Beijing, Beijing Municipality, 100044, China
Guangzhou Eighth People's Hosp /ID# 156859
Guangzhou, Guangdong, 510060, China
Guangdong General Hospital /ID# 156822
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University /ID# 156860
Guangzhou, Guangdong, 510515, China
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156900
Guangzhou, Guangdong, 510630, China
Xiangya Hospital Central South University /ID# 156901
Changsha, Hunan, 410008, China
The Second Hospital of Nanjing /ID# 156863
Nanjing, Jiangsu, 210003, China
Jiangsu Province People's Hospital /ID# 156861
Nanjing, Jiangsu, 210029, China
The First Hosp of Jilin Univ /ID# 156820
Changchun, Jilin, 130021, China
The Sixth People's Hospital of Shenyang /ID# 156849
Shenyang, Liaoning, 110006, China
Shanghai Changzheng Hospital /ID# 158072
Shanghai, Shanghai Municipality, 200003, China
Ruijin Hospital, Shanghai Jiaotong /ID# 157336
Shanghai, Shanghai Municipality, 200025, China
Huashan Hospital of Fudan University /ID# 156904
Shanghai, Shanghai Municipality, 200040, China
Shanghai Public Health Cli Ctr /ID# 156832
Shanghai, Shanghai Municipality, 201508, China
West China Hospital /ID# 156830
Chengdu, Sichuan, 610041, China
Beijing Di Tan Hospital, Capital Medical University /ID# 156847
Beijing, 100015, China
1st Hospital of Peking Uni /ID# 156845
Beijing, 100034, China
302 Military Hospital Of China /ID# 156841
Beijing, 100039, China
Beijing Friendship Hospital /ID# 156840
Beijing, 100050, China
Beijing Youan Hosp, Cap Med Un /ID# 163430
Beijing, 100069, China
1st Affiliated Hosp 3rd Milita /ID# 156831
Chongqing, 400038, China
Dalian Sixth Peoples Hospital /ID# 163433
Dalian, 116031, China
Mengchao Hepatobiliary Hospita /ID# 156902
Fuzhou, 350025, China
Hainan General Hospital /ID# 156839
Haikou, Hainan, 570311, China
Jinan Infectious Diseases Hosp /ID# 156886
Jinan, Shandong, 250021, China
Chinese People's Liberation Army 81 Hospital /ID# 156862
Nanjing, 210002, China
Shengjing Hospital of China Medical University /ID# 156824
Shenyang, 110004, China
Tianjin Third Central Hospital /ID# 156816
Tianjin, 300170, China
1st Aff Hosp Xinjiang Med Uni /ID# 156887
Ürümqi, 830054, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 156884
Wuhan, 430022, China
Tongji Hosp Tongji Med College /ID# 156885
Wuhan, 430030, China
Fourth Military Medical University Tangdu Hospital, PLA /ID# 156765
Xi'an, 710038, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163432
Xi'an, 710061, China
Henan Provincial Peoples Hosp /ID# 157197
Zhengzhou, Henan, 450000, China
National University Hospital ( /ID# 163272
Singapore, 119228, Singapore
Singapore General Hospital /ID# 163271
Singapore, 169608, Singapore
Changi General Hospital /ID# 163270
Singapore, 529889, Singapore
Pusan National University Hosp /ID# 163371
Busan, Busan Gwang Yeogsi, 602-739, South Korea
Seoul National Univ Bundang ho /ID# 163367
Seongnam, Gyeonggido, 13620, South Korea
Inje University Busan Paik Hospital /ID# 163329
Pusan, Gyeongsangbuk-do, 47392, South Korea
Pusan Nat Univ Yangsan Hosp /ID# 163334
Yangsan, Gyeongsangnam-do, 50612, South Korea
Inha University Hospital /ID# 163320
Junggu, Incheon Gwang Yeogsi, 22332, South Korea
Yonsei University Health System, Severance Hospital /ID# 163339
Seodaemun-gu, Seoul Teugbyeolsi, 03722, South Korea
Samsung Medical Center /ID# 163364
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Cath Univ Seoul St Mary's Hosp /ID# 163341
Seoul, Seoul Teugbyeolsi, 06591, South Korea
Korea Universtiy Guro Hospital /ID# 163380
Seoul, Seoul Teugbyeolsi, 08308, South Korea
Seoul National University Hospital /ID# 163348
Seoul, 03080, South Korea
Asan Medical Center /ID# 163336
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2017
First Posted
July 19, 2017
Study Start
October 4, 2017
Primary Completion
October 18, 2018
Study Completion
February 15, 2019
Last Updated
December 23, 2019
Results First Posted
December 23, 2019
Record last verified: 2019-11
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.