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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