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



Status:Completed
Conditions:Infectious Disease, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:9/5/2018
Start Date:January 25, 2017
End Date:August 29, 2018

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M16-126 A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir
(ABT-493)/pibrentasvir (ABT-530) 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, who are either HCV treatment-naïve or treatment experienced with interferon (IFN)
or pegylated interferon (pegIFN) with or without ribavirin (RBV) (defined as P/R
treatment-experienced) or sofosbuvir (SOF) plus RBV with or without pegIFN (defined as SOF
plus RBV treatment-experienced).


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.
We found this trial at
6
sites
San Diego, California 92154
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Kingswood, New South Wales
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Kingswood,
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8700 Beverly Blvd
Los Angeles, California 90048
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Los Angeles, CA
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4275 El Cajon Boulevard
San Diego, California 92105
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San Diego, CA
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San Francisco, California 94110
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San Francisco, CA
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Seattle, Washington 98109
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Seattle, WA
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