Clinical trial NCT02966795: A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus (HCV)
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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-11-17
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
timeFrame: 12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)
Secondary outcomes:
measure: Percentage of Participants With On-treatment HCV Virologic Failure
timeFrame: 8 or 12 weeks (depending on the treatment regimen)
measure: Percentage of Participants With Relapse
timeFrame: End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research & Education, Inc. /ID# 157042
state: California
city: San Diego
country: United States
facility: Kaiser Permanente /ID# 157044
state: California
city: San Francisco
country: United States
facility: Zuckerberg San Francisco Gener /ID# 157040
state: California
city: West Hollywood
country: United States
facility: Cedars-Sinai Medical Center - West Hollywood /ID# 157045
state: California
city: Philadelphia
country: United States
facility: Einstein Medical Center /ID# 157436
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington /ID# 157041
state: Washington
city: Kingswood
country: Australia
facility: Nepean Hospital Kingswood /ID# 157027
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital /ID# 157025
state: Queensland
city: Parkville
country: Australia
facility: Royal Melbourne Hospital /ID# 157024
state: Victoria
city: Kortrijk
country: Belgium
facility: AZ Groeninge /ID# 157029
city: Leuven
country: Belgium
facility: UZ Leuven /ID# 157030
city: Calgary
country: Canada
facility: University of Calgary /ID# 157031
state: Alberta
city: Toronto
country: Canada
facility: Toronto General Hospital /ID# 157032
state: Ontario
city: Pessac CEDEX
country: France
facility: Hopital Haut-Lévêque /ID# 157035
state: Gironde
city: Clichy
country: France
facility: Hopital Beaujon /ID# 157028
state: Ile-de-France
city: Clermont Ferrand
country: France
facility: CHU Estaing /ID# 157034
city: Paris
country: France
facility: Hopital Saint Antoine /ID# 157036
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies Ltd /ID# 157033
city: Singapore
country: Singapore
facility: National University Hospital /ID# 156855
city: Singapore
country: Singapore
facility: Singapore General Hospital /ID# 157037
city: Johannesburg
country: South Africa
facility: Wits Clinical Research Site /ID# 157038
state: Gauteng
city: Cape Town
country: South Africa
facility: University of Cape Town /ID# 157039
state: Western Cape
city: Hanoi
country: Vietnam
facility: National Hospital of Tropical Diseases /ID# 162282
city: Ho Chi Minh
country: Vietnam
facility: Hoa Hao Medic Co. Ltd. /ID# 162283
city: Ho Chi Minh
country: Vietnam
facility: Tropical Diseases Hospital /ID# 162281
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.