A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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), HBV deoxyribonucleic acid \> lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),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.
Clareo Health | A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
