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Hepatitis C Virus (HCV)Phase 3ENDURANCE-5 6NCT02966795

A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

A Phase 3 study testing Glecaprevir/Pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 25 sites in 9 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

A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively. 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
84 participants
Where
25 sitesin 9 countries
Study dates
25 Jan 2017to 29 Aug 2018
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

  • Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.
  • Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at Screening Visit.
  • Participant must be HCV treatment-naïve (i.e., has never received a single dose of any approved or investigational anti-HCV medication) or treatment-experienced (i.e., has failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed greater than or equal to 2 months prior to screening.
  • Participant must be documented as having no cirrhosis or compensated cirrhosis.

Who cannot join

  • Female participant who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
  • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
  • Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
  • HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
  • History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.

Trial locations and contacts

25 sites in 9 countries.

25 sites in 9 countries

United States6 sites

  • Einstein Medical Center /ID# 157436

    Philadelphia, Pennsylvania, 19141

  • Research & Education, Inc. /ID# 157042

    San Diego, California, 92105

  • Kaiser Permanente /ID# 157044

    San Diego, California, 92154

  • Zuckerberg San Francisco Gener /ID# 157040

    San Francisco, California, 94110

  • University of Washington /ID# 157041

    Seattle, Washington, 98109

  • Cedars-Sinai Medical Center - West Hollywood /ID# 157045

    West Hollywood, California, 90048

Other trials in United States

France4 sites

  • CHU Estaing /ID# 157034

    Clermont-Ferrand, 63100

  • Hopital Beaujon /ID# 157028

    Clichy, Île-de-France Region, 92110

  • Hopital Saint Antoine /ID# 157036

    Paris, 75012

  • Hopital Haut-Lévêque /ID# 157035

    Pessac, Gironde, 33604

Other trials in France

Australia3 sites

  • Royal Brisbane and Women's Hospital /ID# 157025

    Herston, Queensland, 4029

  • Nepean Hospital Kingswood /ID# 157027

    Kingswood, New South Wales, 2747

  • Royal Melbourne Hospital /ID# 157024

    Parkville, Victoria, 3050

Other trials in Australia

Vietnam3 sites

  • National Hospital of Tropical Diseases /ID# 162282

    Hanoi, 100000

  • Hoa Hao Medic Co. Ltd. /ID# 162283

    Ho Chi Minh City, 700000

  • Tropical Diseases Hospital /ID# 162281

    Ho Chi Minh City

Other trials in Vietnam

Belgium2 sites

  • AZ Groeninge /ID# 157029

    Kortrijk, 8500

  • UZ Leuven /ID# 157030

    Leuven, 3000

Other trials in Belgium

Canada2 sites

  • University of Calgary /ID# 157031

    Calgary, Alberta, T2N 4Z6

  • Toronto General Hospital /ID# 157032

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Singapore2 sites

  • National University Hospital /ID# 156855

    Singapore, 119074

  • Singapore General Hospital /ID# 157037

    Singapore, 169608

Other trials in Singapore

South Africa2 sites

  • University of Cape Town /ID# 157039

    Cape Town, Western Cape, 7925

  • Wits Clinical Research Site /ID# 157038

    Johannesburg, Gauteng, 2193

Other trials in South Africa

New Zealand1 site

  • Auckland Clinical Studies Ltd /ID# 157033

    Auckland, 1010

Other trials in New Zealand

About this study

Official title: A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.

Being tested
Glecaprevir/Pibrentasvir
Keywords
glecaprevir, pibrentasvir, compensated cirrhosis, non-cirrhotic, interferon (IFN), pegylated interferon (pegIFN), ribavirin (RBV), sofosbuvir (SOF), Sustained Virologic Response 12 weeks post dosing (SVR12), Chronic, Genotype 5 or 6 Infection
Medical subject headings
Hepatitis C, Bronchiolitis Obliterans Syndrome

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™

    Fixed-dose combination tablets taken orally once a day.

Study groups in NCT02966795
Study groupRoleWhat they receive
Glecaprevir/Pibrentasvir for 8 WeeksExperimentalNon-cirrhotic participants with hepatitis C virus genotype 5 or 6 received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 8 weeks, according to label.
Receives: Drug: Glecaprevir/Pibrentasvir
Glecaprevir/Pibrentasvir for 12 WeeksExperimentalParticipants with hepatitis C virus genotype 5 or 6 and compensated cirrhosis received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 12 weeks, according to label.
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 is defined as 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 actual dose of study drug.

    Measured: 12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)

Secondary outcomes (2)

  1. Percentage of Participants With On-treatment HCV Virologic Failure

    HCV virologic failure was defined as one of the following conditions:

    • confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during the Treatment Period; or 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
    • HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.

    Measured: 8 or 12 weeks (depending on the treatment regimen)

  2. Percentage of Participants With Relapse

    Relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.

    Measured: End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.

Timeline

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

  1. First posted17 Nov 2016 (estimated)
  2. Study start25 Jan 2017
  3. Primary completion6 Jun 2018
  4. Study completion29 Aug 2018

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02966795
Sponsor's protocol ID
M16-126
Other IDs
2016-003192-22, 2016
Acronym
ENDURANCE-5 6
Status last verified
Jul 2021
First submitted
15 Nov 2016
Last updated
30 Jul 2021
Data monitoring committee
No
FDA-regulated drug
Yes
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.
Expanded access
Available

Publications

  • Asselah T, Lee SS, Yao BB, Nguyen T, Wong F, Mahomed A, Lim SG, Abergel A, Sasadeusz J, Gane E, Zadeikis N, Schnell G, Zhang Z, Porcalla A, Mensa FJ, Nguyen K. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):45-51. doi: 10.1016/S2468-1253(18)30341-8. Epub 2018 Nov 2.

    PubMed 30393106

  • Brown RS Jr, Collins MA, Strasser SI, Emmett A, Topp AS, Burroughs M, Ferreira R, Feld JJ. Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension. Infect Dis Ther. 2022 Apr;11(2):913-924. doi: 10.1007/s40121-022-00599-8. Epub 2022 Feb 17.

    PubMed 35174470

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 25 sites in 9 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 4 inclusion and 5 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 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, France, Australia, Vietnam, Belgium and 4 more countries. 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 10 Jul 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 last dose of study drug (week 20 or 24 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 NCT02966795, which also lists 2 linked publications.

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 30 Jul 2021.

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