A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis



Status:Active, not recruiting
Conditions:Gastrointestinal, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:April 28, 2017
End Date:November 10, 2019

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A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic
HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with
glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response
12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir
compared to the historical SVR12 rates of 12 weeks of treatment with
glecaprevir/pibrentasvir.


Inclusion Criteria:

- Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6
infection.

- Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000
IU/mL at Screening.

- Treatment-naive to any approved or investigational anti-HCV medication.

- Participant must be documented as cirrhotic, with a Child-Pugh score of less than or
equal to 6.

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.

- Any current or historical clinical evidence of decompensated cirrhosis.

- Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti
human immunodeficiency virus antibody (HIV Ab).

- HCV genotype performed by the central laboratory during screening indicating
co-infection with more than one HCV genotype.

- History of suspected or confirmed hepatocellular carcinoma.
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Allentown, Pennsylvania 18103
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Atlanta, Georgia 30309
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Bakersfield, California 93301
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Baltimore, Maryland 21202
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Des Moines, Iowa 50309
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Durham, North Carolina 27710
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Fayetteville, North Carolina 28304
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Huntersville, North Carolina 28078
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Jackson, MS
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Little Rock, Arkansas 72205
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5901 East 7th Street
Long Beach, California 90822
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Los Angeles, California 90033
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Louisville, Kentucky 40202
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600 Highland Avenue
Madison, Wisconsin 53705
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Miami, Florida 33136
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1215 21st Avenue South
Nashville, Tennessee 37232
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350 West Thomas Road
Phoenix, Arizona 85013
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Phoenix, Arizona 85054
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Pittsburgh, Pennsylvania 15213
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San Diego, California 92154
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Shreveport, Louisiana 71105
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Tulsa, Oklahoma 74127
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West Palm Beach, Florida 33401
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