Clinical trial NCT01439373 (phase 2, status: completed)
Conditions: hepatitis c, chronic
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4
Drugs: gsk2336805, pegylated interferon alfa-2a, ribavirin, gsk2336805 matching placebo
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Key Inclusion Criteria:

          -  Documented chronic genotype 1 or genotype 4 HCV infection

          -  Naïve to all HCV antiviral treatment(s)

          -  Agree to IL28B genotyping

          -  A body mass index >18 kg/m2 but not exceeding 36 kg/m2

          -  Liver biopsy obtained within 3 years (36 calendar months) prior to the Day 1 visit,
             with a fibrosis classification of non-cirrhotic. If no recent (<36 months) liver
             biopsy is available, a study qualifying biopsy must be performed prior to Baseline
             (Day 1)

          -  All fertile males and females must use two forms of effective contraception between
             them during treatment and during the 24 weeks after treatment ends

          -  Otherwise healthy as determined by the medical history, physical examination, ECG
             findings, and clinical laboratory measurements performed at Screening

        Key Exclusion Criteria:

          -  Positive test at Screening for hepatitis B surface antigen (HBsAg) or anti-human
             immunodeficiency virus antibody

          -  History of any other clinically significant chronic liver disease

          -  History of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions
             consistent with decompensated liver disease

          -  Positive results on urine screen for drugs of abuse test at Screening (unless used as
             medical treatment, e.g., with a prescription)

          -  History of alcohol/drug abuse or dependence within 6 months of the study start (unless
             participating in a controlled rehabilitation program)

          -  Screening ECG corrected QT interval value greater than 450 ms and/or clinically
             significant ECG findings

          -  A personal or family history of Torsade de Pointes findings

          -  Pregnant or nursing women

          -  Males with a female partner who is pregnant

          -  Abnormal hematological and biochemical parameters as specified in the protocol

          -  History of major organ transplantation with an existing functional graft

          -  Thyroid dysfunction not adequately controlled

          -  Subjects with a history of suicide attempt or hospitalization for depression in the
             past 5 years and/or any current (within 6 months) severe or poorly controlled
             psychiatric disorder

          -  History or current evidence of immunologic disorder; pulmonary, cardiac, or pulmonary
             disease; seizure disorder; cancer or history of malignancy that in the opinion of the
             investigator makes the subject unsuitable for the study

          -  Participation in a clinical study with an investigational drug, biologic, or device
             within 3 months prior to first dose administration