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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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This study is a multicenter, randomized, active comparator-controlled, double-blind, parallel-group comparison study in Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue and its subsequent open-label study. Efficacy and safety will be compared between once-daily dosing of GSK548470 300 mg and once-daily dosing of ETV 0.5 mg, and subsequently the efficacy and safety of GSK548470 administered long term will be investigated. A total of 165 subjects will be assigned to the GSK548470 group or the ETV group at a ratio of 2:1. The subjects will be assigned by stratified randomization in terms of HBe antigen and serum HBV-DNA level. The primary purpose is to verify the non-inferiority of GSK548470 to ETV using as an index the change amount of HBV-DNA level at Week 24 from the baseline level. The secondary purpose is to investigate the efficacy and safety of GSK548470 300 mg administered once daily for a long term.

Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GSK548470 300 mg

GSK548470 300 mg tablet and ETV placebo capsule are administered once daily

Group Type EXPERIMENTAL

GSK548470 300 mg tablet

Intervention Type DRUG

Blue tablets, each tablet containing 300 mg of tenofovir disoproxil fumarate

ETV 0.5 mg

ETV 0.5 mg capsule and GSK548470 placebo tablet are administered once daily

Group Type ACTIVE_COMPARATOR

ETV 0.5 mg capsule

Intervention Type DRUG

Brown capsules, each capsule containing 0.53 mg of entecavir hydrate

Interventions

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GSK548470 300 mg tablet

Blue tablets, each tablet containing 300 mg of tenofovir disoproxil fumarate

Intervention Type DRUG

ETV 0.5 mg capsule

Brown capsules, each capsule containing 0.53 mg of entecavir hydrate

Intervention Type DRUG

Other Intervention Names

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GSK548470 ETV

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No