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Hepatitis C Virus (HCV)Phase 3VOYAGE-2NCT03235349

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

A Phase 3 study testing Glecaprevir/Pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 34 sites in 2 countries.

Completed

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

Official record
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Trial 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… 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?
No, everyone receives an active treatment
How many people
160 participants
Where
34 sitesin 2 countries
Study dates
29 Sep 2017to 25 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) 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;
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  • 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.

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:
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  • 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

34 sites in 2 countries.

34 sites in 2 countries

China25 sites

  • Peking University Peoples Hospit /ID# 156851

    Beijing, Beijing Municipality, 100044

  • Beijing Di Tan Hospital, Capital Medical University /ID# 156852

    Beijing, 100015

  • 1st Hospital of Peking Uni /ID# 156850

    Beijing, 100034

  • Beijing Friendship Hospital /ID# 156843

    Beijing, 100050

  • Beijing Youan Hosp, Cap Med Un /ID# 163418

    Beijing, 100069

  • The First Hosp of Jilin Univ /ID# 156825

    Changchun, Jilin, 130021

  • West China Hospital /ID# 156835

    Chengdu, Sichuan, 610041

  • 2nd Affiliated Hosp Chongqing /ID# 156838

    Chongqing, 400010

  • Mengchao Hepatobiliary Hospita /ID# 156907

    Fuzhou, 350025

  • Guangzhou Eighth People's Hosp /ID# 156865

    Guangzhou, Guangdong, 510060

  • Guangdong General Hospital /ID# 156827

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital of Southern Medical University /ID# 156866

    Guangzhou, Guangdong, 510515

  • The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156905

    Guangzhou, Guangdong, 510630

  • The Second Hospital of Nanjing /ID# 156869

    Nanjing, Jiangsu, 210003

  • Jiangsu Province People's Hospital /ID# 156867

    Nanjing, Jiangsu, 210029

  • Chinese People's Liberation Army 81 Hospital /ID# 156868

    Nanjing, 210002

  • Ruijin Hospital, Shanghai Jiaotong /ID# 157337

    Shanghai, Shanghai Municipality, 200025

  • Huashan Hospital of Fudan University /ID# 156909

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Public Health Cli Ctr /ID# 156837

    Shanghai, Shanghai Municipality, 201508

  • The Sixth People's Hospital of Shenyang /ID# 156854

    Shenyang, Liaoning, 110006

  • Shengjing Hospital of China Medical University /ID# 156829

    Shenyang, 110004

  • 1st Aff Hosp Xinjiang Med Uni /ID# 156891

    Ürümqi, 830054

  • Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767

    Xi'an, 710038

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163420

    Xi'an, 710061

  • Henan Provincial Peoples Hosp /ID# 157371

    Zhengzhou, Henan, 450000

Other trials in China

South Korea9 sites

  • Pusan National University Hosp /ID# 163411

    Busan, Busan Gwang Yeogsi, 602-739

  • Inje University Busan Paik Hospital /ID# 163384

    Pusan, Gyeongsangbuk-do, 47392

  • Seoul National Univ Bundang ho /ID# 163408

    Seongnam, Gyeonggido, 13620

  • Severance Hospital /ID# 163399

    Seoul, Seoul Teugbyeolsi, 03722

  • Samsung Medical Center /ID# 163402

    Seoul, Seoul Teugbyeolsi, 06351

  • Korea University Guro Hospital /ID# 163412

    Seoul, Seoul Teugbyeolsi, 08308

  • Seoul National University Hospital /ID# 163401

    Seoul, 03080

  • Asan Medical Center /ID# 163398

    Seoul, 05505

  • Pusan Nat Univ Yangsan Hosp /ID# 163385

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

About this study

Official title: 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

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.

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

What participants receive

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

  • Glecaprevir/PibrentasvirDrug

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

    Coformulated tablet for oral administration

Study groups in NCT03235349
Study groupRoleWhat they receive
Glecaprevir/PibrentasvirExperimentalParticipants 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.
Receives: Drug: Glecaprevir/Pibrentasvir

What is being measured

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

  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.

    Measured: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.

Secondary outcomes (3)

  1. Percentage of Participants 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: 12 or 16 weeks depending on the treatment regimen

  2. Percentage of Participants 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 (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).

  3. Percentage of HCV/HIV Co-infected Participants Achieving SVR12

    SVR12 was defined as plasma HCV RNA level less than LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.

    Measured: 12 weeks after the last actual dose of study drug, Week 24 or Week 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 posted1 Aug 2017
  2. Study start29 Sep 2017
  3. Primary completion15 Nov 2018
  4. Study completion25 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03235349
Sponsor's protocol ID
M15-593
Acronym
VOYAGE-2
Status last verified
Aug 2019
First submitted
28 Jul 2017
Last updated
21 Nov 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 34 sites in 2 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 13 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 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China, South Korea. 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 21 Nov 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 Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.). 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 NCT03235349, 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 21 Nov 2019.

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