Overview

Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B With Poor Response to Other Drugs

Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
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.
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 <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