(TURQUOISE-CPB)

Study Design

• The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
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  Allocation

  Non-Randomized

• A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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  Endpoint Classification

  Safety/Efficacy Study

• The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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  Intervention Model

  Parallel Assignment

• The general design that describes the strategy for identifying and following up with participants during observational studies.
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  Masking

  Open Label

• This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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  Purpose

  Treatment

Eligibility Criteria
• HCV Genotype 1(GT1)- or Genotype 4 (GT4)-infection defined as: Positive for anti-HCV Ab, HCV RNA > 1,000 IU/mL and laboratory result indicating HCV GT1 infection at Screening.
• Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., CT or MRI).
• Child-Pugh Score 7 - 9 inclusive at time of Screening.
Exclusion Criteria
• Women who are pregnant or breastfeeding.
• Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab).
• Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegylated interferon (pegIFN)/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir).
• Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI).
• Any current or past evidence of Child-Pugh C classification.