NCT01480284

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2011

Typical duration for phase_3

Geographic Reach
1 country

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 29, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

August 10, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

November 23, 2011

Results QC Date

August 22, 2013

Last Update Submit

July 7, 2016

Conditions

Hepatitis B, Chronic

Keywords

Tenofovir Disoproxil FumarateChronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Serum HBV DNA Level at Week 24

    The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

    Baseline and Week 24

Secondary Outcomes (11)

  • Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96

    Baseline, Week 48 and Week 96

  • Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96

    Week 24, Week 48 and Week 96

  • Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96

    Week 24, Week 48 and Week 96

  • Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96

    Week 24, Week 48 and Week 96

  • Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96

    Week 24, Week 48 and Week 96

  • +6 more secondary outcomes

Study Arms (2)

GSK548470 300 mg

EXPERIMENTAL

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

Drug: GSK548470 300 mg tablet

ETV 0.5 mg

ACTIVE COMPARATOR

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

Drug: ETV 0.5 mg capsule

Interventions

GSK548470 300 mg tabletDRUG

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

Also known as: GSK548470
GSK548470 300 mg
ETV 0.5 mg capsuleDRUG

Brown capsules, each capsule containing 0.53 mg of entecavir hydrate

Also known as: ETV
ETV 0.5 mg

Eligibility Criteria

Age16 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The ability to understand and sign a written informed consent form
  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

GSK Investigational Site

Aichi, 466-8560, Japan

Location

GSK Investigational Site

Aichi, 467-8602, Japan

Location

GSK Investigational Site

Chiba, 260-8677, Japan

Location

GSK Investigational Site

Fukui, 918-8503, Japan

Location

GSK Investigational Site

Fukuoka, 803-8505, Japan

Location

GSK Investigational Site

Fukuoka, 810-8539, Japan

Location

GSK Investigational Site

Fukuoka, 812-8582, Japan

Location

GSK Investigational Site

Fukuoka, 820-8505, Japan

Location

GSK Investigational Site

Gifu, 500-8717, Japan

Location

GSK Investigational Site

Hiroshima, 734-8530, Japan

Location

GSK Investigational Site

Hyōgo, 651-2273, Japan

Location

GSK Investigational Site

Hyōgo, 663-8501, Japan

Location

GSK Investigational Site

Kagawa, 760-8557, Japan

Location

GSK Investigational Site

Kagoshima, 890-8520, Japan

Location

GSK Investigational Site

Kagoshima, 892-8512, Japan

Location

GSK Investigational Site

Kanagawa, 213-8587, Japan

Location

GSK Investigational Site

Kumamoto, 862-8655, Japan

Location

GSK Investigational Site

Miyagi, 980-8574, Japan

Location

GSK Investigational Site

Miyazaki, 880-0003, Japan

Location

GSK Investigational Site

Nagasaki, 852-8501, Japan

Location

GSK Investigational Site

Nagasaki, 856-8562, Japan

Location

GSK Investigational Site

Nara, 630-8305, Japan

Location

GSK Investigational Site

Okayama, 700-0913, Japan

Location

GSK Investigational Site

Okayama, 700-8511, Japan

Location

GSK Investigational Site

Osaka, 540-0006, Japan

Location

GSK Investigational Site

Osaka, 564-0013, Japan

Location

GSK Investigational Site

Saga, 840-8571, Japan

Location

GSK Investigational Site

Tokyo, 105-8470, Japan

Location

GSK Investigational Site

Tokyo, 105-8471, Japan

Location

GSK Investigational Site

Tokyo, 140-8522, Japan

Location

GSK Investigational Site

Tokyo, 162-8655, Japan

Location

GSK Investigational Site

Tokyo, 180-8610, Japan

Location

Related Publications (1)

  • Koike K, Suyama K, Ito H, Itoh H, Sugiura W. Randomized prospective study showing the non-inferiority of tenofovir to entecavir in treatment-naive chronic hepatitis B patients. Hepatol Res. 2018 Jan;48(1):59-68. doi: 10.1111/hepr.12902. Epub 2017 May 24.

    PMID: 28374496DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tabletsentecavir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 28, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2013

Study Completion

November 1, 2014

Last Updated

August 10, 2016

Results First Posted

October 29, 2013

Record last verified: 2016-07

Locations

JP(32)