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: Completed
• Trial end date: 2019-11-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie

Criteria

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), 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.