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CompletedNCT01475851Updated Jun 22, 2015Results posted

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

A Phase 3 interventional study of GSK548470 300 mg tablet in Hepatitis B, Chronic, sponsored by GlaxoSmithKline. Completed at 11 sites in Japan. Open to participants aged 16 Years to 69 Years. Per ClinicalTrials.gov, last updated 2015-06-22.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
16 Years to 69 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Hepatitis B, Chronic

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Keywords

  • Tenofovir disoproxil fumarate, compensated chronic hepatitis B
03

In context

Hepatitis B, Chronic

954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.

This study's enrollment of 34 is below the median of 100 across 692 interventional studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    GSK548470 300 mg

    GSK548470 300 mg tablet is administered orally once daily

    Drug: GSK548470 300 mg tablet

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24

    The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level \< the lower limit of quantitation (2.1 log10 copies/millilitres\[copies/mL\]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA \<2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.

    Time frame: Week 24

Secondary outcomes

  1. Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96

    The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24, Week 48 and Week 96 were assessed (HBV DNA values below the lower limit of quantitation \[i.e. 2.1 log10 copies/mL\] for the assay were set to the lower limit minus 0.1 \[i.e. 2.0 log10 copies/mL\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Last Observation Carried Forward (LOCF) method was applied for missing values.

    Time frame: Baseline and Week 24, Week 48 and Week 96

  2. Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96

    The number of participants with serum HBV DNA level \< the lower limit of quantitation (2.1 log10 copies/mL) (i.e., the rate of suppression) at Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.

    Time frame: Week 48 and Week 96

  3. 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.

    Time frame: Week 24, Week 48 and Week 96

  4. 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.

    Time frame: Week 24, Week 48 and Week 96

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

    The number of participants achieving hepatitis Be antigen (HBeAg)/hepatitis B e 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 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

  6. 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.

    Time frame: Week 24, Week 48 and Week 96

  7. Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96

    The number of participants with hepatitis B surface antigen (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 was 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

  8. Number of Participants With Virological Breakthrough and Resistance-related Mutations

    The number of participants who harbored resistance-related mutations and developed virological breakthrough was summarized. Virological breakthrough defined as HBV DNA level increase \>=1 log10 copies/mL above the treatment nadir were analyzed through end of treatment. Subjects who achieved the HBV-DNA values below lower limit of quantification (LLQ) (\< 2.1 log10 copies/mL) in quantitative analysis at Week 96 were also considered "negative" in drug-resistance without implementation of genotypic analysis. Lamivudine (LAM), adefovir pivoxil (ADV), and entecavir hydrate (ETV) resistance-related mutations were analyzed at Screening (i.e. Baseline), Week 24, Week 48 and Week 96 in participants with HBV DNA level above the lower limit of detection. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV DNA levels from on-treatment nadir. The LOCF method was applied for missing values.

    Time frame: Screening, Week 24, Week 48, Week 96 and Virological Breakthrough

  9. Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96

    The number of participants achieving each indicated hepatitis B surface antigen (HBsAg) category (HBsAg \<80, 80 to 800, 800 to 8000, 8000 to 80000, \>=80000) (kilo international unit per liter \[KIU/L\]) by study visit was summarized.

    Time frame: Baseline, Week 24, Week 48 and Week 96

  10. 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 log10, 3.0 to 4.0 log10, 4.0 to 5.0 log10, 5.0 to 6.0 log10, \>=6.0 log10) (kilo units 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

07

Results

Posted Nov 4, 2013

Participant flow

Participant flow — Overall Study
MilestoneLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
Started1321
Completed1221
Not completed10
Withdrew: Protocol defined stopping criteria10

Outcome measures

PrimaryNumber of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24

The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level \< the lower limit of quantitation (2.1 log10 copies/millilitres\[copies/mL\]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA \<2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.

Time frame:
Week 24
Reported as:
Number · participants
Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24
participantsLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24812
SecondaryMean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96

The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24, Week 48 and Week 96 were assessed (HBV DNA values below the lower limit of quantitation \[i.e. 2.1 log10 copies/mL\] for the assay were set to the lower limit minus 0.1 \[i.e. 2.0 log10 copies/mL\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Last Observation Carried Forward (LOCF) method was applied for missing values.

Time frame:
Baseline and Week 24, Week 48 and Week 96
Reported as:
Mean · log10 copies/mL
Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96
log10 copies/mLLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
Week 24-2.72 (-3.50 to -1.93)-3.33 (-4.01 to -2.65)
Week 48-2.88 (-3.70 to -2.06)-3.50 (-4.28 to -2.73)
Week 96-3.02 (-3.84 to -2.21)-3.50 (-4.35 to -2.66)
SecondaryNumber of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96

The number of participants with serum HBV DNA level \< the lower limit of quantitation (2.1 log10 copies/mL) (i.e., the rate of suppression) at Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.

Time frame:
Week 48 and Week 96
Reported as:
Number · participants
Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96
participantsLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
Week 48912
Week 961014
SecondaryNumber 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.

Time frame:
Week 24, Week 48 and Week 96
Reported as:
Number · participants
Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96
participantsLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
Week 2436
Week 4835
Week 9636
SecondaryNumber 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.

Time frame:
Week 24, Week 48 and Week 96
Reported as:
Number · participants
Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96
participantsLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
Week 2400
Week 4810
Week 9610
SecondaryNumber of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96

The number of participants achieving hepatitis Be antigen (HBeAg)/hepatitis B e 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 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
Reported as:
Number · participants
Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96
participantsLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
Week 2400
Week 4800
Week 9600
SecondaryNumber 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.

Time frame:
Week 24, Week 48 and Week 96
Reported as:
Number · participants
Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96
participantsLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
Week 2400
Week 4800
Week 9600
SecondaryNumber of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96

The number of participants with hepatitis B surface antigen (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 was 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
Reported as:
Number · participants
Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96
participantsLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
Week 2400
Week 4800
Week 9600
SecondaryNumber of Participants With Virological Breakthrough and Resistance-related Mutations

The number of participants who harbored resistance-related mutations and developed virological breakthrough was summarized. Virological breakthrough defined as HBV DNA level increase \>=1 log10 copies/mL above the treatment nadir were analyzed through end of treatment. Subjects who achieved the HBV-DNA values below lower limit of quantification (LLQ) (\< 2.1 log10 copies/mL) in quantitative analysis at Week 96 were also considered "negative" in drug-resistance without implementation of genotypic analysis. Lamivudine (LAM), adefovir pivoxil (ADV), and entecavir hydrate (ETV) resistance-related mutations were analyzed at Screening (i.e. Baseline), Week 24, Week 48 and Week 96 in participants with HBV DNA level above the lower limit of detection. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV DNA levels from on-treatment nadir. The LOCF method was applied for missing values.

Time frame:
Screening, Week 24, Week 48, Week 96 and Virological Breakthrough
Reported as:
Number · participants
Number of Participants With Virological Breakthrough and Resistance-related Mutations
participantsLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
Virological breakthrough, through end of study n=001
LAM resistance-related mutations,Screening,n=13,211117
ADV resistance-related mutations,Screening,n=13,2140
ETV resistance-related mutations,Screening,n=13,21616
LAM resistance-related mutations, Week 24, n=5, 948
ADV resistance-related mutations, Week 24, n=5, 920
ETV resistance-related mutations, Week 24, n=5, 918
LAM resistance-related mutations, Week 48, n= 3, 927
ADV resistance-related mutations, Week 48, n= 3, 910
ETV resistance-related mutations, Week 48, n= 3, 917
LAM resistance-related mutations, Week 96, n= 2, 726
ADV resistance-related mutations, Week 96, n= 2, 710
ETV resistance-related mutations, Week 96, n= 2, 726
LAM resistance-related mutations, VB, n=0,101
ADV resistance-related mutations, VB, n=0,100
ETV resistance-related mutations, VB, n=0,101
SecondaryNumber of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96

The number of participants achieving each indicated hepatitis B surface antigen (HBsAg) category (HBsAg \<80, 80 to 800, 800 to 8000, 8000 to 80000, \>=80000) (kilo international unit per liter \[KIU/L\]) by study visit was summarized.

Time frame:
Baseline, Week 24, Week 48 and Week 96
Reported as:
Number · participants
Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96
participantsLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
HBsAg <80 KIU/L, Baseline00
HBsAg 80-800 KIU/L, Baseline10
HBsAg 800-8000 KIU/L, Baseline612
HBsAg 8000-80,000 KIU/L, Baseline68
HBsAg >=80,000 KIU/L, Baseline01
HBsAg <80 KIU/L, Week 2400
HBsAg 80-800 KIU/L, Week 2430
HBsAg 800-8000 KIU/L, Week 24515
HBsAg 8000-80,000 KIU/L, Week 2456
HBsAg >=80,000 KIU/L, Week 2400
HBsAg <80 KIU/L, Week 4800
HBsAg 80-800 KIU/L, Week 4831
HBsAg 800-8000 KIU/L, Week 48514
HBsAg 8000-80,000 KIU/L, Week 4856
HBsAg >=80,000 KIU/L, Week 4800
HBsAg <80 KIU/L, Week 9600
HBsAg 80-800 KIU/L, Week 9643
HBsAg 800-8000 KIU/L, Week 96613
HBsAg 8000-80,000 KIU/L, Week 9635
HBsAg >=80,000 KIU/L, Week 9600
SecondaryNumber 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 log10, 3.0 to 4.0 log10, 4.0 to 5.0 log10, 5.0 to 6.0 log10, \>=6.0 log10) (kilo units 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
Reported as:
Number · Participants
Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96
ParticipantsLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
HBcrAg <3.0 Log KU/L, Baseline00
HBcrAg 3.0-4.0 Log KU/L, Baseline01
HBcrAg 4.0-5.0 Log KU/L, Baseline01
HBcrAg 5.0-6.0 Log KU/L, Baseline10
HBcrAg >=6.0 Log KU/L, Baseline1219
HBcrAg <3.0 Log KU/L, Week 2400
HBcrAg 3.0-4.0 Log KU/L, Week 2401
HBcrAg 4.0-5.0 Log KU/L, Week 2411
HBcrAg 5.0-6.0 Log KU/L, Week 2411
HBcrAg >=6.0 Log KU/L, Week 241118
HBcrAg <3.0 Log KU/L, Week 4800
HBcrAg 3.0-4.0 Log KU/L, Week 4811
HBcrAg 4.0-5.0 Log KU/L, Week 4801
HBcrAg 5.0-6.0 Log KU/L, Week 4821
HBcrAg >=6.0 Log KU/L, Week 481018
HBcrAg <3.0 Log KU/L, Week 9600
HBcrAg 3.0-4.0 Log KU/L, Week 9611
HBcrAg 4.0-5.0 Log KU/L, Week 9601
HBcrAg 5.0-6.0 Log KU/L, Week 9632
HBcrAg >=6.0 Log KU/L, Week 96917

Adverse events

Collected over Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LAM 100 mg/TDF 300 mg—1/13 (7.7%)12/13 (92.3%)
ETV 0.5 mg/TDF 300 mg—2/21 (9.5%)17/21 (81%)
Most frequent serious events
Most frequent serious events
EventLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
Lumbar spinal stenosisMusculoskeletal and connective tissue disorders1/130/21
Calculus uretericRenal and urinary disorders0/131/21
AppendicitisInfections and infestations0/131/21
Most frequent other events
Showing 10 of 40
Most frequent other events
EventLAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mg
NasopharyngitisInfections and infestations7/1311/21
HeadacheNervous system disorders2/132/21
Gallbladder polypHepatobiliary disorders2/130/21
DiarrhoeaGastrointestinal disorders0/133/21
RashSkin and subcutaneous tissue disorders1/133/21
Alanine aminotransferase increasedInvestigations1/133/21
Hepatic steatosisHepatobiliary disorders1/133/21
DyspepsiaGastrointestinal disorders1/132/21
Abdominal discomfortGastrointestinal disorders0/132/21
Abdominal painGastrointestinal disorders0/132/21

Baseline characteristics

Age, Continuous
Age, Continuous(Years)LAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mgTotal
Mean52.1 ± 7.5750.3 ± 9.1851.0 ± 8.52
Sex: Female, Male
Sex: Female, Male(Participants)LAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mgTotal
Female549
Male81725
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)LAM 100 mg/TDF 300 mgETV 0.5 mg/TDF 300 mgTotal
Asian-Japanese Heritage132134
08

Study locations

11 sites
  • GSK Investigational Site
    Aichi, 466-8560, Japan
  • GSK Investigational Site
    Aichi, 467-8602, Japan
  • GSK Investigational Site
    Chiba, 260-8677, Japan
  • GSK Investigational Site
    Fukuoka, 803-8505, Japan
  • GSK Investigational Site
    Hiroshima, 734-8551, Japan
  • GSK Investigational Site
    Hokkaido, 060-0033, Japan
  • GSK Investigational Site
    Kagoshima, 890-8520, Japan
  • GSK Investigational Site
    Kanagawa, 213-8587, Japan
  • GSK Investigational Site
    Miyagi, 980-8574, Japan
  • GSK Investigational Site
    Tokyo, 105-8470, Japan
  • GSK Investigational Site
    Tokyo, 180-8610, Japan
09

References and documents

Publications

  • Kumada H, Koike K, Suyama K, Ito H, Itoh H, Sugiura W. Efficacy and safety of tenofovir disoproxil fumarate rescue therapy for chronic hepatitis B patients who failed other nucleos(t)ide analogs. Hepatol Res. 2017 Sep;47(10):1032-1041. doi: 10.1111/hepr.12842. Epub 2016 Dec 21. PubMed 27862721 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01475851
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 21, 2011
Start date
Dec 2011
Primary completion
Jun 2013
Completion
Oct 2014
Results posted
Nov 4, 2013
Last update
Jun 22, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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