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

Completed · Phase 3

Conditions studied: Hepatitis C Virus (HCV)

In brief

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.

Key facts

Study ID

NCT02966795

Run by

AbbVie

People needed

84

Starts

2017-01-25

Expected to finish

2018-08-29

Last updated by the study team

2021-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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