A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
ENDURANCE-5 6
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
2 other identifiers
interventional
84
9 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2017
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedStudy Start
First participant enrolled
January 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2018
CompletedResults Posted
Study results publicly available
July 10, 2019
CompletedJuly 30, 2021
July 1, 2021
1.4 years
November 15, 2016
June 6, 2019
July 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)
Secondary Outcomes (2)
Percentage of Participants With On-treatment HCV Virologic Failure
8 or 12 weeks (depending on the treatment regimen)
Percentage of Participants With Relapse
End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.
Study Arms (2)
Glecaprevir/Pibrentasvir for 8 Weeks
EXPERIMENTALNon-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.
Glecaprevir/Pibrentasvir for 12 Weeks
EXPERIMENTALParticipants 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.
Interventions
Fixed-dose combination tablets taken orally once a day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (25)
Research & Education, Inc. /ID# 157042
San Diego, California, 92105, United States
Kaiser Permanente /ID# 157044
San Diego, California, 92154, United States
Zuckerberg San Francisco Gener /ID# 157040
San Francisco, California, 94110, United States
Cedars-Sinai Medical Center - West Hollywood /ID# 157045
West Hollywood, California, 90048, United States
Einstein Medical Center /ID# 157436
Philadelphia, Pennsylvania, 19141, United States
University of Washington /ID# 157041
Seattle, Washington, 98109, United States
Nepean Hospital Kingswood /ID# 157027
Kingswood, New South Wales, 2747, Australia
Royal Brisbane and Women's Hospital /ID# 157025
Herston, Queensland, 4029, Australia
Royal Melbourne Hospital /ID# 157024
Parkville, Victoria, 3050, Australia
AZ Groeninge /ID# 157029
Kortrijk, 8500, Belgium
UZ Leuven /ID# 157030
Leuven, 3000, Belgium
University of Calgary /ID# 157031
Calgary, Alberta, T2N 4Z6, Canada
Toronto General Hospital /ID# 157032
Toronto, Ontario, M5G 2C4, Canada
Hopital Haut-Lévêque /ID# 157035
Pessac, Gironde, 33604, France
CHU Estaing /ID# 157034
Clermont-Ferrand, 63100, France
Hopital Saint Antoine /ID# 157036
Paris, 75012, France
Hopital Beaujon /ID# 157028
Clichy, Île-de-France Region, 92110, France
Auckland Clinical Studies Ltd /ID# 157033
Auckland, 1010, New Zealand
National University Hospital /ID# 156855
Singapore, 119074, Singapore
Singapore General Hospital /ID# 157037
Singapore, 169608, Singapore
Wits Clinical Research Site /ID# 157038
Johannesburg, Gauteng, 2193, South Africa
University of Cape Town /ID# 157039
Cape Town, Western Cape, 7925, South Africa
National Hospital of Tropical Diseases /ID# 162282
Hanoi, 100000, Vietnam
Hoa Hao Medic Co. Ltd. /ID# 162283
Ho Chi Minh City, 700000, Vietnam
Tropical Diseases Hospital /ID# 162281
Ho Chi Minh City, Vietnam
Related Publications (2)
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.
PMID: 30393106BACKGROUNDBrown 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.
PMID: 35174470DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 15, 2016
First Posted
November 17, 2016
Study Start
January 25, 2017
Primary Completion
June 6, 2018
Study Completion
August 29, 2018
Last Updated
July 30, 2021
Results First Posted
July 10, 2019
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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.