A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Purpose
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.
Condition
- Hepatitis C Virus (HCV)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks |
Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks. |
|
More Details
- Status
- Completed
- Sponsor
- AbbVie