NCT03212521
Brief summary
A study to evaluate the efficacy and safety of an active drug in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
Inclusion Criteria:
- Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and
indeterminate GT may be acceptable.
- Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or
equal to 1, at time of screening.
- Does not have current active hepatitis B virus infection defined as:
- positive hepatitis B surface antigen (HBsAg), OR
- hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of
quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core
(HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs])
- Platelets ≥ 150,000 cells/mm³
- Albumin ≥ lower limit of normal (LLN)
- Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥
1,000 IU/mL at Screening and for at least 6 months before Screening.
- No past history/evidence of cirrhosis.
- No history of hepatocellular carcinoma.
- Hepatitis C virus treatment-naïve (had not received a single dose of any approved or
investigational anti-HCV medication).
- If female, the subject must not be pregnant, breastfeeding, or considering becoming
pregnant during the study and for 30 days after the last dose of study drug.
