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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Hepatitis B, Chronic

Treatments

Drug: GSK548470 300 mg tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01475851

115912

Details and patient eligibility

About

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.

Full description

This is a multicenter, open-label study in Japanese patients with compensated chronic hepatitis B with poor response to other drugs in order to evaluate the efficacy and safety of GSK548470 administered at a dose of 300 mg once daily. The target sample size is set at 32 subjects. The primary objective is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in subjects with compensated chronic hepatitis B with poor response to other drugs. The secondary objective is to evaluate the long-term efficacy and safety of once-daily treatment with GSK548470 300 mg.To evaluate the efficacy and safety of GSK548470 in the study, subjects receiving a combination of lamivudine (LAM) and adefovir pivoxil (ADV) will be switched to a combination of LAM and GSK548470, while subjects on entecavir hydrate (ETV) with or without ADV will be switched to a combination of ETV and GSK548470.

Enrollment

34 patients

Sex

All

Ages

16 to 69 years old

Volunteers

No Healthy Volunteers

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