A Study to Evaluate Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection, With APRI (a Predictor of Hepatic Fibrosis) ≤ 1, and Have Never Received HCV Treatment



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:8/23/2018
Start Date:August 7, 2017
End Date:August 13, 2018

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A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1-6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1

A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in
treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and
with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.


Inclusion Criteria:

- Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1, 2, 3,
4, 5 or 6 infection. Mixed GT and indeterminate GT may be acceptable.

- A negative hepatitis B surface antigen (HBsAg), and negative anti-hepatitis B core
(HBc) or; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than the lower
limit of quantification (LLOQ) in participants with isolated positive anti-HBc. (For
sites participating in Bulgaria, France, Germany, Poland, Russia, Spain, and UK)

- Does not have current active HBV infection defined as positive HBsAg or HBV DNA
greater than or equal to LLOQ in subjects with isolated positive anti-HBc (i.e
negative HBsAg and anti-HBs. (For sites in United States, Puerto Rico, and Canada)

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

- Aspartate aminotransferase to Platelet Ratio Index (APRI) score of less than or equal
to 1, at time of screening.

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

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.

- History of hepatocellular carcinoma (HCC).
We found this trial at
12
sites
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Ann Arbor, MI
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Baltimore, Maryland 21201
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Baltimore, MD
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Baltimore, MD
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1160 Huffman Road
Birmingham, Alabama 35215
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Birmingham, AL
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Burlington, VT
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6410 Fannin Street
Houston, Texas 77030
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Houston, TX
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New Haven, Connecticut 06510
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New Haven, CT
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Norfolk, VA
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3401 Springhill Road
North Little Rock, Arkansas 72117
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North Little Rock, AR
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Portland, OR
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2315 Stockton Boulevard
Sacramento, California 95817
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Sacramento, CA
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