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

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
GSK548470 300 mg tablet
ETV 0.5 mg capsule
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Tenofovir Disoproxil Fumarate, Chronic Hepatitis B

Eligibility Criteria

16 Years - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept 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 < 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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GSK548470 300 mg

ETV 0.5 mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96
The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 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. The LOCF method was applied for missing values.
Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96
The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.
Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96
The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.
Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96
The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.
Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96
The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.
Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96
The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.
Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96
The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
The number of participants achieving each indicated HBsAg category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, and >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized. The LOCF method was applied for missing values.
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96
The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and >=6.0) (Log kilo unit per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values.
Number of Participants With Virological Breakthrough Through End of the Study
The number of participants who experienced virological breakthrough was summarized. Virological breakthrough is defined as serum HBV DNA level increase >=1 log10 copies/mL above the treatment nadir. Virological breakthrough values were presented from Baseline to through out the study. Baseline is defined as the value at Week 0 visit.
Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study)
The development of drug resistance-related (RA) mutations was analyzed to look for resistance to Lamivudine (LAM), Adefovir dipivoxil (ADV), and/or ETV in a case where a virologic breakthrough has been observed after starting the study treatment (serum HBV DNA level has increased from the nadir by at least 1 log10 copies/mL) or where the serum HBV DNA level is not less than the HBV DNA detection limit (2.1 log10 copies/mL) at Week 24, Week 48 and Week 96. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV-DNA levels from on-treatment nadir. Participants who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at entire the study were also considered "Negative" in drug-resistance without implementation of genotypic analysis. Resistance mutation values were presented from Baseline to throughout the study. Baseline is defined as the value at Week 0 visit.

Full Information

First Posted
November 23, 2011
Last Updated
July 7, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01480284
Brief Title
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue
Official Title
A Multi-center, Randomized, Active Controlled, Double-blind, Parallel Group Comparison Study and Subsequent Open-label Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Tenofovir Disoproxil Fumarate, Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GSK548470 300 mg
Arm Type
Experimental
Arm Description
GSK548470 300 mg tablet and ETV placebo capsule are administered once daily
Arm Title
ETV 0.5 mg
Arm Type
Active Comparator
Arm Description
ETV 0.5 mg capsule and GSK548470 placebo tablet are administered once daily
Intervention Type
Drug
Intervention Name(s)
GSK548470 300 mg tablet
Other Intervention Name(s)
GSK548470
Intervention Description
Blue tablets, each tablet containing 300 mg of tenofovir disoproxil fumarate
Intervention Type
Drug
Intervention Name(s)
ETV 0.5 mg capsule
Other Intervention Name(s)
ETV
Intervention Description
Brown capsules, each capsule containing 0.53 mg of entecavir hydrate
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Serum HBV DNA Level at Week 24
Description
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.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96
Description
The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 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. The LOCF method was applied for missing values.
Time Frame
Baseline, Week 48 and Week 96
Title
Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96
Description
The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.
Time Frame
Week 24, Week 48 and Week 96
Title
Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96
Description
The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.
Time Frame
Week 24, Week 48 and Week 96
Title
Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96
Description
The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.
Time Frame
Week 24, Week 48 and Week 96
Title
Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96
Description
The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.
Time Frame
Week 24, Week 48 and Week 96
Title
Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96
Description
The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.
Time Frame
Week 24, Week 48 and Week 96
Title
Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96
Description
The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.
Time Frame
Week 24, Week 48 and Week 96
Title
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
Description
The number of participants achieving each indicated HBsAg category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, and >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized. The LOCF method was applied for missing values.
Time Frame
Baseline, Week 24, Week 48 and Week 96
Title
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96
Description
The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and >=6.0) (Log kilo unit per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values.
Time Frame
Baseline, Week 24, Week 48 and Week 96
Title
Number of Participants With Virological Breakthrough Through End of the Study
Description
The number of participants who experienced virological breakthrough was summarized. Virological breakthrough is defined as serum HBV DNA level increase >=1 log10 copies/mL above the treatment nadir. Virological breakthrough values were presented from Baseline to through out the study. Baseline is defined as the value at Week 0 visit.
Time Frame
From Baseline to throughout study
Title
Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study)
Description
The development of drug resistance-related (RA) mutations was analyzed to look for resistance to Lamivudine (LAM), Adefovir dipivoxil (ADV), and/or ETV in a case where a virologic breakthrough has been observed after starting the study treatment (serum HBV DNA level has increased from the nadir by at least 1 log10 copies/mL) or where the serum HBV DNA level is not less than the HBV DNA detection limit (2.1 log10 copies/mL) at Week 24, Week 48 and Week 96. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV-DNA levels from on-treatment nadir. Participants who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at entire the study were also considered "Negative" in drug-resistance without implementation of genotypic analysis. Resistance mutation values were presented from Baseline to throughout the study. Baseline is defined as the value at Week 0 visit.
Time Frame
Screening, Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to throughout the study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
GSK Investigational Site
City
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
GSK Investigational Site
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
803-8505
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
810-8539
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
GSK Investigational Site
City
Gifu
ZIP/Postal Code
500-8717
Country
Japan
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
GSK Investigational Site
City
Hyogo
ZIP/Postal Code
651-2273
Country
Japan
Facility Name
GSK Investigational Site
City
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
GSK Investigational Site
City
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
GSK Investigational Site
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
GSK Investigational Site
City
Kagoshima
ZIP/Postal Code
892-8512
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
213-8587
Country
Japan
Facility Name
GSK Investigational Site
City
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Facility Name
GSK Investigational Site
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
GSK Investigational Site
City
Miyazaki
ZIP/Postal Code
880-0003
Country
Japan
Facility Name
GSK Investigational Site
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
GSK Investigational Site
City
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
GSK Investigational Site
City
Nara
ZIP/Postal Code
630-8305
Country
Japan
Facility Name
GSK Investigational Site
City
Okayama
ZIP/Postal Code
700-0913
Country
Japan
Facility Name
GSK Investigational Site
City
Okayama
ZIP/Postal Code
700-8511
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
564-0013
Country
Japan
Facility Name
GSK Investigational Site
City
Saga
ZIP/Postal Code
840-8571
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
140-8522
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
180-8610
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28374496
Citation
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.
Results Reference
derived

Learn more about this trial

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

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