ENDURANCE-5 6
Brief summary
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of an active drug for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
Inclusion Criteria:
- Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.
- Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid
(RNA) greater than or equal to 1000 IU/mL at Screening Visit.
- Participant must be HCV treatment-naïve (i.e., has never received a single dose of any
approved or investigational anti-HCV medication) or treatment-experienced (i.e., has
failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without
ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior
HCV treatment with any other approved or investigational medications is not allowed.
Previous HCV treatment must have been completed greater than or equal to 2 months
prior to screening.
- Participant must be documented as having no cirrhosis or compensated cirrhosis.
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.
- Recent (within 6 months prior to study drug administration) history of drug or alcohol
abuse that could preclude adherence to the protocol in the opinion of the
investigator.
- Positive test result at screening for hepatitis B surface antigen (HBsAg) or
anti-human immunodeficiency virus antibody (HIV Ab).
- HCV genotype performed during screening indicating co-infection with more than one HCV
genotype.
- History of severe, life-threatening or other significant sensitivity to any excipients
of the study drug.
