Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: GSK548470 300 mg tablet
Intervention description: Blue tablets containing 300 mg of tenofovir disoproxil fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 16 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Tenofovir disoproxil fumarate, compensated chronic hepatitis B

Summary:

      The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with
      GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response
      to other drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The ability to understand and sign a written informed consent form

          -  16 to 69 years of age at the time of informed consent

          -  Females of childbearing potential must have a negative pregnancy test and agree to
             avoidance of pregnancy

          -  Subject must show QTc <450 millisecond (msec) or <480msec with Bundle Branch Block

          -  Chronic HBV infection, defined as positive serum HBsAg for at least 6 month

          -  Subjects currently treated with LAM/ADV, ETV or ETV/ADV for greater than 24 weeks

          -  Chronic hepatitis B ; HBV NDA >= 4 log10 copies/mL, Chronic hepatitis B with cirrhosis
             ; HBV NDA >= 3 log10 copies/mL

          -  Serum ALT <= 10 × ULN

          -  Creatinine clearance >= 70 mL/min

          -  Haemoglobin >= 8 g/dL

          -  WBC >= 1,000 /mm3

        Exclusion Criteria:

          -  Decompensated liver disease

          -  Co-infection with HIV or HCV

          -  Autoimmune hepatitis rather than chronic hepatitis B

          -  Subject with serious complication

          -  Received or have a plan for solid organ or bone marrow transplantation

          -  Has proximal tubulopathy

          -  History of hypersensitivity to nucleoside and/or nucleotide analogues

          -  Evidence of hepatocellular carcinoma by diagnostic imaging at screening and/or serum
             α-fetoprotein > 50 ng/mL at screening

          -  History of HCC

          -  Received any interferon or HB vaccine therapy within 24 weeks prior to initiation

          -  Received overdose NSAIDs, excluding temporary or topical use, within 7 days prior to
             initiation

          -  Received drugs for injection containing glycyrrhizin as the main component within 4
             weeks prior to initiation

          -  Received drugs causing renal impairment, competitors of renal excretion,
             immunosuppressants, chemotherapeutics and/or corticosteroids within 8 weeks prior to
             initiation

          -  Participation in another clinical study within 6 months of study entry or planned
             participation in another clinical study after entry to this study

          -  Woman who is pregnant, lactating, possibly pregnant or planning a pregnancy during the
             study period

          -  Psychiatry disorder or cognitive disorder that may affect the subject ability to give
             informed consent or to follow specified study procedures

          -  History of alcohol or drug abuse

          -  Any condition or situation that may interfere with the subject's participation in the
             study