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Hepatitis C Virus (HCV)Phase 3VOYAGE-1NCT03222583

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

A Phase 3 study testing Glecaprevir/Pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 48 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus (HCV)
What is being tested?
Glecaprevir/Pibrentasvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
546 participants
Where
48 sitesin 3 countries
Study dates
4 Oct 2017to 15 Feb 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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:
Show all 9Show fewer
  • 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.

Trial locations and contacts

48 sites in 3 countries.

48 sites in 3 countries

China34 sites

  • Peking University Peoples Hospit /ID# 156846

    Beijing, Beijing Municipality, 100044

  • Beijing Di Tan Hospital, Capital Medical University /ID# 156847

    Beijing, 100015

  • 1st Hospital of Peking Uni /ID# 156845

    Beijing, 100034

  • 302 Military Hospital Of China /ID# 156841

    Beijing, 100039

  • Beijing Friendship Hospital /ID# 156840

    Beijing, 100050

  • Beijing Youan Hosp, Cap Med Un /ID# 163430

    Beijing, 100069

  • The First Hosp of Jilin Univ /ID# 156820

    Changchun, Jilin, 130021

  • Xiangya Hospital Central South University /ID# 156901

    Changsha, Hunan, 410008

  • West China Hospital /ID# 156830

    Chengdu, Sichuan, 610041

  • 1st Affiliated Hosp 3rd Milita /ID# 156831

    Chongqing, 400038

  • Dalian Sixth Peoples Hospital /ID# 163433

    Dalian, 116031

  • Mengchao Hepatobiliary Hospita /ID# 156902

    Fuzhou, 350025

  • Guangzhou Eighth People's Hosp /ID# 156859

    Guangzhou, Guangdong, 510060

  • Guangdong General Hospital /ID# 156822

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital of Southern Medical University /ID# 156860

    Guangzhou, Guangdong, 510515

  • The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156900

    Guangzhou, Guangdong, 510630

  • Hainan General Hospital /ID# 156839

    Haikou, Hainan, 570311

  • Jinan Infectious Diseases Hosp /ID# 156886

    Jinan, Shandong, 250021

  • The Second Hospital of Nanjing /ID# 156863

    Nanjing, Jiangsu, 210003

  • Jiangsu Province People's Hospital /ID# 156861

    Nanjing, Jiangsu, 210029

  • Chinese People's Liberation Army 81 Hospital /ID# 156862

    Nanjing, 210002

  • Shanghai Changzheng Hospital /ID# 158072

    Shanghai, Shanghai Municipality, 200003

  • Ruijin Hospital, Shanghai Jiaotong /ID# 157336

    Shanghai, Shanghai Municipality, 200025

  • Huashan Hospital of Fudan University /ID# 156904

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Public Health Cli Ctr /ID# 156832

    Shanghai, Shanghai Municipality, 201508

  • The Sixth People's Hospital of Shenyang /ID# 156849

    Shenyang, Liaoning, 110006

  • Shengjing Hospital of China Medical University /ID# 156824

    Shenyang, 110004

  • Tianjin Third Central Hospital /ID# 156816

    Tianjin, 300170

  • 1st Aff Hosp Xinjiang Med Uni /ID# 156887

    Ürümqi, 830054

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 156884

    Wuhan, 430022

  • Tongji Hosp Tongji Med College /ID# 156885

    Wuhan, 430030

  • Fourth Military Medical University Tangdu Hospital, PLA /ID# 156765

    Xi'an, 710038

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163432

    Xi'an, 710061

  • Henan Provincial Peoples Hosp /ID# 157197

    Zhengzhou, Henan, 450000

Other trials in China

South Korea11 sites

  • Pusan National University Hosp /ID# 163371

    Busan, Busan Gwang Yeogsi, 602-739

  • Inha University Hospital /ID# 163320

    Junggu, Incheon Gwang Yeogsi, 22332

  • Inje University Busan Paik Hospital /ID# 163329

    Pusan, Gyeongsangbuk-do, 47392

  • Yonsei University Health System, Severance Hospital /ID# 163339

    Seodaemun-gu, Seoul Teugbyeolsi, 03722

  • Seoul National Univ Bundang ho /ID# 163367

    Seongnam, Gyeonggido, 13620

  • Samsung Medical Center /ID# 163364

    Seoul, Seoul Teugbyeolsi, 06351

  • Cath Univ Seoul St Mary's Hosp /ID# 163341

    Seoul, Seoul Teugbyeolsi, 06591

  • Korea Universtiy Guro Hospital /ID# 163380

    Seoul, Seoul Teugbyeolsi, 08308

  • Seoul National University Hospital /ID# 163348

    Seoul, 03080

  • Asan Medical Center /ID# 163336

    Seoul, 05505

  • Pusan Nat Univ Yangsan Hosp /ID# 163334

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Singapore3 sites

  • National University Hospital ( /ID# 163272

    Singapore, 119228

  • Singapore General Hospital /ID# 163271

    Singapore, 169608

  • Changi General Hospital /ID# 163270

    Singapore, 529889

Other trials in Singapore

About this study

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

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.

Read the 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.

Being tested
Placebo, Glecaprevir/Pibrentasvir
Keywords
Chronic Hepatitis C Virus (HCV), Genotype 1 to 6, Asian, non-cirrhotic, Human Immunodeficiency Virus, co-infection, Treatment-naïve, Treatment-experienced, interferon
Medical subject headings
Hepatitis C, Hepatitis C, Chronic, Acquired Immunodeficiency Syndrome, Coinfection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Matching placebo tablet for oral administration

  • Glecaprevir/PibrentasvirDrug

    Also called ABT-493/ABT-530, MAVYRET™

    Coformulated tablet for oral administration

Study groups in NCT03222583
Study groupRoleWhat they receive
Glecaprevir/PibrentasvirExperimentalParticipants 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.
Receives: Drug: Glecaprevir/Pibrentasvir
Placebo / Glecaprevir/PibrentasvirExperimentalParticipants 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.
Receives: Drug: Placebo; Drug: Glecaprevir/Pibrentasvir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen.

  2. 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.

    Measured: 12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen

  3. 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.

    Measured: 12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen.

Secondary outcomes (3)

  1. 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.

    Measured: 8 or 16 weeks depending on the treatment regimen

  2. 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.

    Measured: 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).

  3. 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.

    Measured: 12 weeks after the last actual dose of study drug, Week 20 or 28 depending on the treatment regimen

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2017
  2. Study start4 Oct 2017
  3. Primary completion18 Oct 2018
  4. Study completion15 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
546 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03222583
Sponsor's protocol ID
M15-592
Acronym
VOYAGE-1
Status last verified
Nov 2019
First submitted
17 Jul 2017
Last updated
23 Dec 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 32682494

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glecaprevir/Pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 48 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in China, South Korea, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03222583, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.

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