EXPEDITION-8
Brief 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 withan active drug and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with an active drug compared to the historical SVR12 rates of 12 weeks of treatment with an active drug.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
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.
