Back to resultsA 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)
Primary Purpose
Hepatitis C Virus (HCV)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Glecaprevir/Pibrentasvir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus (HCV) focused on measuring Chronic Hepatitis C Virus (HCV), Genotype 1 to 6, Asian, non-cirrhotic, Human Immunodeficiency Virus, co-infection, Treatment-naïve, Treatment-experienced, interferon
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Additional Exclusion Criteria for participants with HCV/HIV Co-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.
Sites / Locations
- Peking University Peoples Hospit /ID# 156846
- Guangzhou Eighth People's Hosp /ID# 156859
- Guangdong General Hospital /ID# 156822
- Nanfang Hospital of Southern Medical University /ID# 156860
- The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156900
- Xiangya Hospital Central South University /ID# 156901
- The Second Hospital of Nanjing /ID# 156863
- Jiangsu Province People's Hospital /ID# 156861
- The First Hosp of Jilin Univ /ID# 156820
- The Sixth People's Hospital of Shenyang /ID# 156849
- Shanghai Changzheng Hospital /ID# 158072
- Ruijin Hospital, Shanghai Jiaotong /ID# 157336
- Huashan Hospital of Fudan University /ID# 156904
- Shanghai Public Health Cli Ctr /ID# 156832
- West China Hospital /ID# 156830
- Beijing Di Tan Hospital, Capital Medical University /ID# 156847
- 1st Hospital of Peking Uni /ID# 156845
- 302 Military Hospital Of China /ID# 156841
- Beijing Friendship Hospital /ID# 156840
- Beijing Youan Hosp, Cap Med Un /ID# 163430
- 1st Affiliated Hosp 3rd Milita /ID# 156831
- Dalian Sixth Peoples Hospital /ID# 163433
- Mengchao Hepatobiliary Hospita /ID# 156902
- Hainan General Hospital /ID# 156839
- Jinan Infectious Diseases Hosp /ID# 156886
- Chinese People's Liberation Army 81 Hospital /ID# 156862
- Shengjing Hospital of China Medical University /ID# 156824
- Tianjin Third Central Hospital /ID# 156816
- 1st Aff Hosp Xinjiang Med Uni /ID# 156887
- Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 156884
- Tongji Hosp Tongji Med College /ID# 156885
- Fourth Military Medical University Tangdu Hospital, PLA /ID# 156765
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163432
- Henan Provincial Peoples Hosp /ID# 157197
- Pusan National University Hosp /ID# 163371
- Seoul National Univ Bundang ho /ID# 163367
- Inje University Busan Paik Hospital /ID# 163329
- Pusan Nat Univ Yangsan Hosp /ID# 163334
- Inha University Hospital /ID# 163320
- Yonsei University Health System, Severance Hospital /ID# 163339
- Samsung Medical Center /ID# 163364
- Cath Univ Seoul St Mary's Hosp /ID# 163341
- Korea Universtiy Guro Hospital /ID# 163380
- Seoul National University Hospital /ID# 163348
- Asan Medical Center /ID# 163336
- National University Hospital ( /ID# 163272
- Singapore General Hospital /ID# 163271
- Changi General Hospital /ID# 163270
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Glecaprevir/Pibrentasvir
Placebo / Glecaprevir/Pibrentasvir
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Percentage of Participants in Arm A With On-treatment Virologic Failure
On-treatment virologic failure was defined as meeting one of the following:
confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or
confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or
HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.
Percentage of Participants in Arm A With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, excluding re-infection.
Percentage of HCV/HIV Co-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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03222583
Brief Title
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
Acronym
VOYAGE-1
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
February 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Randomization was stratified by geographic region (China, South Korea, Singapore), genotype (GT1, GT2, combined GT3 - 6), and HCV/HIV co-infection status (co-infected, not co-infected). In China, eligible participants were randomized to Arm A or Arm B (defined below) in the following ratios: 2:1 for GT1, 2:1 for GT2, and 2:1 for combined GT3-6. In South Korea and Singapore, eligible participants were randomized to Arm A or Arm B in the following ratios: 2:1 for GT1 and 2:1 for GT2.
All Primary and Secondary Outcome Measures were pre-specified to be analyzed only in Arm A.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus (HCV)
Keywords
Chronic Hepatitis C Virus (HCV), Genotype 1 to 6, Asian, non-cirrhotic, Human Immunodeficiency Virus, co-infection, Treatment-naïve, Treatment-experienced, interferon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
546 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glecaprevir/Pibrentasvir
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo / Glecaprevir/Pibrentasvir
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet for oral administration
Intervention Type
Drug
Intervention Name(s)
Glecaprevir/Pibrentasvir
Other Intervention Name(s)
ABT-493/ABT-530, MAVYRET™
Intervention Description
Coformulated tablet for oral administration
Primary Outcome Measure Information:
Title
Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Description
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.
Time Frame
12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
Title
Percentage of HCV GT1-Infected Participants in Arm A Who Achieved SVR12
Description
SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug.
Time Frame
12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen
Title
Percentage of HCV GT2-Infected Participants in Arm A Who Achieved SVR12
Description
SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last actual dose of study drug.
Time Frame
12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
Secondary Outcome Measure Information:
Title
Percentage of Participants in Arm A With On-treatment Virologic Failure
Description
On-treatment virologic failure was defined as meeting one of the following:
confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or
confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or
HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.
Time Frame
8 or 16 weeks depending on the treatment regimen
Title
Percentage of Participants in Arm A With Post-treatment Relapse
Description
Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, excluding re-infection.
Time Frame
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).
Title
Percentage of HCV/HIV Co-infected Participants in Arm A Who Achieved SVR12
Description
SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug.
Time Frame
12 weeks after the last actual dose of study drug, Week 20 or 28 depending on the treatment regimen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Additional Exclusion Criteria for participants with HCV/HIV Co-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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Peoples Hospit /ID# 156846
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Guangzhou Eighth People's Hosp /ID# 156859
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Guangdong General Hospital /ID# 156822
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Nanfang Hospital of Southern Medical University /ID# 156860
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156900
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Xiangya Hospital Central South University /ID# 156901
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Second Hospital of Nanjing /ID# 156863
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210003
Country
China
Facility Name
Jiangsu Province People's Hospital /ID# 156861
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The First Hosp of Jilin Univ /ID# 156820
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The Sixth People's Hospital of Shenyang /ID# 156849
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110006
Country
China
Facility Name
Shanghai Changzheng Hospital /ID# 158072
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong /ID# 157336
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Huashan Hospital of Fudan University /ID# 156904
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Public Health Cli Ctr /ID# 156832
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Facility Name
West China Hospital /ID# 156830
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Beijing Di Tan Hospital, Capital Medical University /ID# 156847
City
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
1st Hospital of Peking Uni /ID# 156845
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
302 Military Hospital Of China /ID# 156841
City
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Beijing Friendship Hospital /ID# 156840
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Youan Hosp, Cap Med Un /ID# 163430
City
Beijing
ZIP/Postal Code
100069
Country
China
Facility Name
1st Affiliated Hosp 3rd Milita /ID# 156831
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Dalian Sixth Peoples Hospital /ID# 163433
City
Dalian
ZIP/Postal Code
116031
Country
China
Facility Name
Mengchao Hepatobiliary Hospita /ID# 156902
City
Fuzhou
ZIP/Postal Code
350025
Country
China
Facility Name
Hainan General Hospital /ID# 156839
City
Haikou, Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Jinan Infectious Diseases Hosp /ID# 156886
City
Jinan, Shandong
ZIP/Postal Code
250021
Country
China
Facility Name
Chinese People's Liberation Army 81 Hospital /ID# 156862
City
Nanjing
ZIP/Postal Code
210002
Country
China
Facility Name
Shengjing Hospital of China Medical University /ID# 156824
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
Tianjin Third Central Hospital /ID# 156816
City
Tianjin
ZIP/Postal Code
300170
Country
China
Facility Name
1st Aff Hosp Xinjiang Med Uni /ID# 156887
City
Urumqi
ZIP/Postal Code
830054
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 156884
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hosp Tongji Med College /ID# 156885
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Fourth Military Medical University Tangdu Hospital, PLA /ID# 156765
City
Xi'an
ZIP/Postal Code
710038
Country
China
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163432
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Henan Provincial Peoples Hosp /ID# 157197
City
Zhengzhou, Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Pusan National University Hosp /ID# 163371
City
Busan
State/Province
Busan Gwang Yeogsi
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Seoul National Univ Bundang ho /ID# 163367
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital /ID# 163329
City
Busan
State/Province
Gyeongsangbugdo
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Pusan Nat Univ Yangsan Hosp /ID# 163334
City
Yangsan-si,
State/Province
Gyeongsangnamdo
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Inha University Hospital /ID# 163320
City
Jung-gu
State/Province
Incheon Gwang Yeogsi
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Yonsei University Health System, Severance Hospital /ID# 163339
City
Seodaemun-gu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 163364
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Cath Univ Seoul St Mary's Hosp /ID# 163341
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Korea Universtiy Guro Hospital /ID# 163380
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 163348
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 163336
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
National University Hospital ( /ID# 163272
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Singapore General Hospital /ID# 163271
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Changi General Hospital /ID# 163270
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
32682494
Citation
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.
Results Reference
derived
Learn more about this trial
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
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