Clinical trial NCT00725803 (phase 2, status: completed)
Conditions: hcv infection
ICD codes: K94.02, K94.12, K94.22, K94.32, N99.511, A02.9, A31.0
Drugs: gs-9450, gs-9450 placebo
SMILES: CC(C)[C@]1(CC(=NO1)C1=NC=CC2=CC=CC=C12)C(=O)N[C@H]1CC(=O)O[C@]1(O)CF, CC(C)[C@]1(CC(=NO1)C1=NC=CC2=CC=CC=C12)C(=O)N[C@H]1CC(=O)O[C@]1(O)CF
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged from 18 to 65 years old, inclusive.

          -  Willing and able to provide written, informed consent

          -  Have a body mass index between 19 and 32 kg/m2, inclusive, at screening.

          -  Have chronic hepatitis C infection of any genotype (and subtype).

          -  Subjects must be previously treated with pegylated interferon (PEG) or interferon
             (INF) with or without ribavirin (RBV) and either did not achieve a sustained viral
             response (undetectable HCV RNA) six months after cessation of anti-viral therapy, or
             did not tolerate PEG or INF with or without RBV therapy. Subjects who have
             contraindications to receiving PEG or INF with or without RBV may also be eligible.

          -  ALT >/= 1.5 X but < 10 X the upper limit of the normal range (ULN); aspartate
             aminotransferase (AST) < 10 X ULN; platelets >/= 75,000/mm3; total bilirubin </= 1.5 X
             ULN; prothrombin time </= 1.5 X ULN; albumin >/= 3.0 g/dL; absolute neutrophil count
             >/= 1,000 cells/mm3; and hemoglobin >/= 10 g/dL

          -  Creatinine clearance >/= 70 mL/min

          -  A female of non-childbearing potential who is documented as either surgically sterile
             or post-menopausal for >/= 2 years.

          -  Females < 2 years post-menopausal are required to have follicle-stimulating hormone
             (FSH) level of >/= 40 mIU/mL. If of child-bearing potential or FSH < 40 mIU/mL, must:

               1. have negative serum pregnancy test and a negative urine pregnancy test, and

               2. agree to use an acceptable method of contraception during heterosexual
                  intercourse during the study and for >/= 30 days or one menstrual cycle
                  (whichever is the longer) after last dose of study drug.

          -  If male, agree to use an acceptable method of contraception during heterosexual
             intercourse during the study and for at least 3 months after the last dose of study
             drug.

          -  Subjects should be in reasonably good health as determined by the Investigator.

        Exclusion Criteria:

          -  Pregnant or breast feeding women or women who may wish to become pregnant during the
             study or within 30 days of study drug administration.

          -  Males who have partners planning to become pregnant within 30 days of study drug
             administration.

          -  Males and females of reproductive potential who are unwilling to use effective
             method(s) of birth control for a minimum of 30 days after ingestion of study
             medication

          -  Coinfection with hepatitis B virus (HBV) or HIV

          -  Known liver disease of a non-HCV etiology

          -  Pancreatitis

          -  Autoimmune disease

          -  History of malignancy

          -  Ongoing alcohol abuse.

          -  Recent significant infection or symptoms of infection

          -  Evidence of hepatocellular carcinoma (e.g., a-fetoprotein > 50 ng/mL or as indicated
             by recent ultrasound)

          -  Decompensated liver disease OR history of clinical hepatic decompensation

          -  Hb < 10 g/dL

          -  Absolute neutrophil count (ANC) < 1,000 cells/mm3

          -  Therapy with potentially hepatotoxic/cholestatic drugs.

          -  Therapy with agents having potential hepatic anti-inflammatory or anti-fibrotic
             properties.

          -  Therapy with proton pump inhibitors or histamine-2 receptor antagonists.

          -  Have received therapy with systemic steroids, immunosuppressant therapies or
             chemotherapeutic agents within 90 days prior to Day 1 or are expected to receive such
             therapy during the study.

          -  With or a history of clinically significant illness or medical disorder that may
             interfere with treatment, assessment or compliance.

          -  Have a history of a primary gastrointestinal disorder that could interfere with the
             absorption of the study drug or that could interfere with normal gastrointestinal
             anatomy or motility.

          -  Received study medication while participating in another research study within 60 days
             prior to Day 1.

          -  A positive urine drug screen

          -  Known hypersensitivity to the study drugs, the metabolites or formulation excipients.

          -  Known aspirin allergy.