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 |
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.
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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