Efficacy and Safety of 8-weeks of an Active Drug in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1

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

Hepatitis C Virus (HCV)
230 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Single Group Assignment
None (Open Label)


Eligibility criteria

Participant attributes:
Male and Female


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.

All the cities where the clinical studies are located

Calgary - T3M 1M4
Brampton - L6R 3J7
Toronto - M6H 3M1
Moncton - E1C 6Z8


New Brunswick

More information about this study