Safety, Antiviral Activity, and Pharmacokinetics of GSK2336805 With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: GSK2336805; Pegylated interferon alfa-2a; Ribavirin; GSK2336805 Matching Placebo
Intervention description: Active Investigational Drug; Standard of Care drug; Standard of Care drug; Placebo of Investigational Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: chronic hepatitis C; NS5A inhibitor; ribavirin; pegylated interferon; GSK2336805

Summary:

      GSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of
      chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and
      pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and
      ribavirin in subjects with chronic hepatitis C (CHC).
    

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