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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02966795
Registration number
NCT02966795
Ethics application status
Date submitted
15/11/2016
Date registered
17/11/2016
Date last updated
30/07/2021
Titles & IDs
Public title
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
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Scientific 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
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Secondary ID [1]
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2016-003192-22
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Secondary ID [2]
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M16-126
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Universal Trial Number (UTN)
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Trial acronym
ENDURANCE-5 6
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus (HCV)
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Glecaprevir/Pibrentasvir
Experimental: Glecaprevir/Pibrentasvir for 8 Weeks - Non-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.
Experimental: Glecaprevir/Pibrentasvir for 12 Weeks - Participants 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.
Treatment: Drugs: Glecaprevir/Pibrentasvir
Fixed-dose combination tablets taken orally once a day.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
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Assessment method [1]
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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.
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Timepoint [1]
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12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)
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Secondary outcome [1]
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Percentage of Participants With On-treatment HCV Virologic Failure
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Assessment method [1]
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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.
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Timepoint [1]
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8 or 12 weeks (depending on the treatment regimen)
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Secondary outcome [2]
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Percentage of Participants With Relapse
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Assessment method [2]
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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.
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Timepoint [2]
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End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.
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Eligibility
Key inclusion criteria
- 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/01/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/08/2018
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Sample size
Target
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Accrual to date
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Final
84
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Nepean Hospital Kingswood /ID# 157027 - Kingswood
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital /ID# 157025 - Herston
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Recruitment hospital [3]
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Royal Melbourne Hospital /ID# 157024 - Parkville
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Recruitment postcode(s) [1]
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2747 - Kingswood
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Pennsylvania
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United States of America
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Washington
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Belgium
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Kortrijk
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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Ontario
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France
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Gironde
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France
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Ile-de-France
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France
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Clermont Ferrand
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France
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Paris
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New Zealand
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Auckland
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Singapore
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Singapore
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South Africa
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Gauteng
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South Africa
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Western Cape
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Vietnam
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State/province [16]
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Hanoi
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Country [17]
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Vietnam
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State/province [17]
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02966795
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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AbbVie Inc.
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Address
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AbbVie
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02966795
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