Clinical Trials

MainTitle

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)

This study has been completed
Sponsor
AbbVie


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT03222583

First received: July 17, 2017
Last updated: December 5, 2019
Last Verified: November 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Hepatitis C Virus (HCV)

Drug : Placebo
Drug : Glecaprevir/Pibrentasvir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen. ]
    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 [ Time Frame: 12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen ]
    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 [ Time Frame: 12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen. ]
    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 [ Time Frame: 8 or 16 weeks depending on the treatment regimen ]
    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 [ 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). ]
    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 [ Time Frame: 12 weeks after the last actual dose of study drug, Week 20 or 28 depending on the treatment regimen ]
    SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug.

Enrollment: 546
Study Start Date: October 4, 2017
Study Completion Date: February 15, 2019
Primary Completion Date: October 18, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 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.
Drug: Glecaprevir/Pibrentasvir

Coformulated tablet for oral administration

Other Name:
  • ABT-493/ABT-530
  • MAVYRET™

Experimental: 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.
Drug: Placebo

Matching placebo tablet for oral administration

Drug: Glecaprevir/Pibrentasvir

Coformulated tablet for oral administration

Other Name:
  • ABT-493/ABT-530
  • MAVYRET™

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03222583

Locations

China
Peking University Peoples Hospit /ID# 156846
Beijing, Beijing, China, 100044
Guangzhou Eighth People's Hosp /ID# 156859
Guangzhou, Guangdong, China, 510060
Guangdong General Hospital /ID# 156822
Guangzhou, Guangdong, China, 510080
Nanfang Hospital of Southern Medical University /ID# 156860
Guangzhou, Guangdong, China, 510515
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156900
Guangzhou, Guangdong, China, 510630
Xiangya Hospital Central South University /ID# 156901
Changsha, Hunan, China, 410008
The Second Hospital of Nanjing /ID# 156863
Nanjing, Jiangsu, China, 210003
Jiangsu Province People's Hospital /ID# 156861
Nanjing, Jiangsu, China, 210029
The First Hosp of Jilin Univ /ID# 156820
Changchun, Jilin, China, 130021
The Sixth People's Hospital of Shenyang /ID# 156849
Shenyang, Liaoning, China, 110006
Shanghai Changzheng Hospital /ID# 158072
Shanghai, Shanghai, China, 200003
Ruijin Hospital, Shanghai Jiaotong /ID# 157336
Shanghai, Shanghai, China, 200025
Huashan Hospital of Fudan University /ID# 156904
Shanghai, Shanghai, China, 200040
Shanghai Public Health Cli Ctr /ID# 156832
Shanghai, Shanghai, China, 201508
West China Hospital /ID# 156830
Chengdu, Sichuan, China, 610041
Beijing Di Tan Hospital, Capital Medical University /ID# 156847
Beijing, China, 100015
1st Hospital of Peking Uni /ID# 156845
Beijing, China, 100034
302 Military Hospital Of China /ID# 156841
Beijing, China, 100039
Beijing Friendship Hospital /ID# 156840
Beijing, China, 100050
Beijing Youan Hosp, Cap Med Un /ID# 163430
Beijing, China, 100069
1st Affiliated Hosp 3rd Milita /ID# 156831
Chongqing, China, 400038
Dalian Sixth Peoples Hospital /ID# 163433
Dalian, China, 116031
Mengchao Hepatobiliary Hospita /ID# 156902
Fuzhou, China, 350025
Hainan General Hospital /ID# 156839
Haikou, Hainan, China, 570311
Jinan Infectious Diseases Hosp /ID# 156886
Jinan, Shandong, China, 250021
Chinese People's Liberation Army 81 Hospital /ID# 156862
Nanjing, China, 210002
Shengjing Hospital of China Medical University /ID# 156824
Shenyang, China, 110004
Tianjin Third Central Hospital /ID# 156816
Tianjin, China, 300170
1st Aff Hosp Xinjiang Med Uni /ID# 156887
Urumqi, China, 830054
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 156884
Wuhan, China, 430022
Tongji Hosp Tongji Med College /ID# 156885
Wuhan, China, 430030
Fourth Military Medical University Tangdu Hospital, PLA /ID# 156765
Xi'an, China, 710038
First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163432
Xi'an, China, 710061
Henan Provincial Peoples Hosp /ID# 157197
Zhengzhou, Henan, China, 450000
Korea, Republic of
Pusan National University Hosp /ID# 163371
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Seoul National Univ Bundang ho /ID# 163367
Seongnam, Gyeonggido, Korea, Republic of, 13620
Inje University Busan Paik Hospital /ID# 163329
Busan, Gyeongsangbugdo, Korea, Republic of, 47392
Pusan Nat Univ Yangsan Hosp /ID# 163334
Yangsan-si,, Gyeongsangnamdo, Korea, Republic of, 50612
Inha University Hospital /ID# 163320
Jung-gu, Incheon Gwang Yeogsi, Korea, Republic of, 22332
Yonsei University Health System, Severance Hospital /ID# 163339
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 163364
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Cath Univ Seoul St Mary's Hosp /ID# 163341
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
Korea Universtiy Guro Hospital /ID# 163380
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
Seoul National University Hospital /ID# 163348
Seoul, Korea, Republic of, 03080
Asan Medical Center /ID# 163336
Seoul, Korea, Republic of, 05505
Singapore
National University Hospital ( /ID# 163272
Singapore, Singapore, 119228
Singapore General Hospital /ID# 163271
Singapore, Singapore, 169608
Changi General Hospital /ID# 163270
Singapore, Singapore, 529889

Sponsors and Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc. AbbVie
More Information

More Information


Responsible Party: AbbVie  
ClinicalTrials.gov Identifier: NCT03222583   History of Changes  
Other Study ID Numbers: M15-592  
Study First Received: July 17, 2017  
Last Updated: December 5, 2019  
Individual Participant Data    
Plan to Share IPD: Yes  

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  

Keywords provided by AbbVie:

Chronic Hepatitis C Virus (HCV)
Genotype 1 to 6
Asian
non-cirrhotic
Human Immunodeficiency Virus
co-infection
Treatment-naïve
Treatment-experienced
interferon

Additional relevant MeSH terms:
Infection
Coinfection
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis, Chronic
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.