A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
NCT ID: NCT02966795
Last Updated: 2021-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2017-01-25
2018-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Glecaprevir/Pibrentasvir
Fixed-dose combination tablets taken orally once a day.
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.
Glecaprevir/Pibrentasvir
Fixed-dose combination tablets taken orally once a day.
Interventions
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Glecaprevir/Pibrentasvir
Fixed-dose combination tablets taken orally once a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Research & Education, Inc. /ID# 157042
San Diego, California, United States
Kaiser Permanente /ID# 157044
San Diego, California, United States
Zuckerberg San Francisco Gener /ID# 157040
San Francisco, California, United States
Cedars-Sinai Medical Center - West Hollywood /ID# 157045
West Hollywood, California, United States
Einstein Medical Center /ID# 157436
Philadelphia, Pennsylvania, United States
University of Washington /ID# 157041
Seattle, Washington, United States
Nepean Hospital Kingswood /ID# 157027
Kingswood, New South Wales, Australia
Royal Brisbane and Women's Hospital /ID# 157025
Herston, Queensland, Australia
Royal Melbourne Hospital /ID# 157024
Parkville, Victoria, Australia
AZ Groeninge /ID# 157029
Kortrijk, , Belgium
UZ Leuven /ID# 157030
Leuven, , Belgium
University of Calgary /ID# 157031
Calgary, Alberta, Canada
Toronto General Hospital /ID# 157032
Toronto, Ontario, Canada
Hopital Haut-Lévêque /ID# 157035
Pessac, Gironde, France
CHU Estaing /ID# 157034
Clermont-Ferrand, , France
Hopital Saint Antoine /ID# 157036
Paris, , France
Hopital Beaujon /ID# 157028
Clichy, Île-de-France Region, France
Auckland Clinical Studies Ltd /ID# 157033
Auckland, , New Zealand
National University Hospital /ID# 156855
Singapore, , Singapore
Singapore General Hospital /ID# 157037
Singapore, , Singapore
Wits Clinical Research Site /ID# 157038
Johannesburg, Gauteng, South Africa
University of Cape Town /ID# 157039
Cape Town, Western Cape, South Africa
National Hospital of Tropical Diseases /ID# 162282
Hanoi, , Vietnam
Hoa Hao Medic Co. Ltd. /ID# 162283
Ho Chi Minh City, , Vietnam
Tropical Diseases Hospital /ID# 162281
Ho Chi Minh City, , Vietnam
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003192-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-126
Identifier Type: -
Identifier Source: org_study_id
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