Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue. In efficacy, the non-inferiority of GSK548470 to ETV will be verified using the antiviral effect as the index.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Tenofovir

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 < 480 msec with Bundle Branch Block

• Chronic HBV infection, defined as positive serum HBsAg for at least 6 month, or negative serum IgM-HBc antibody

• HBeAg positive; HBV-DNA >= 6 log10 copies/mL, HBeAg negative; HBV-DNA >= 5 log10 copies/mL

• Serum ALT >= 31 U/L and <= 10 × ULN

• Creatinine clearance >= 70 mL/min

• Haemoglobin >= 8 g/dL

• WBC >= 1,000 /mm3

• Nucleic acid analogue naïve, i.e., no prior therapy for over 6 months in the past

• No mutation that shows resistance in LAM, ETV and/or TDF at screening

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 nucleoside, nucleotide, 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