A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis

Overview

About this study

A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB) combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated cirrhosis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1, 2, 4, 5 or 6 infection.
  • Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening.
  • Treatment-naÃ-ve 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 genotype 3 infection or co-infection with more than one HCV genotype.
  • History of suspected or confirmed hepatocellular carcinoma.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20348165

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