Status:
COMPLETED
A Study of Switching From Entecavir to Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
20-69 years
Phase:
PHASE4
Brief Summary
Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits Hepatitis B Virus (HBV) growth, and is marketed in Japan with an indication for inhibition of HBV growth in subjects with chroni...
Eligibility Criteria
Inclusion
- Subjects must be 20 to 69 years of age inclusive, at the time of signing the informed consent
- Male and female subjects. A female subject is eligible to participate if she is not pregnant and not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP), OR
- A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 days after the last dose of study treatment
- Capable of giving signed informed consent form (ICF)
- Subjects with chronic hepatitis B (CHB) (excluding hospitalized subjects)
- Subjects treated with ETV for at least 2 years prior to initiation of study treatment.
- The serum HBV-DNA level at screening is below the limit of quantitation (\< 2.1 Log10 copies/milliliter \[mL\] or \< 20 international unit \[IU\]/mL).
- Subjects with serum HBeAg positive at screening
- Meet either of the following serum HBsAg levels at screening:
- Serum HBsAg 80 \< to \< 800 IU/mL and fluctuation range is equal or more than -0.1 Log10 IU/mL per year
- Serum HBsAg \>=800 IU/mL
- Meet all of the following criteria at screening:
- Creatinine clearance (CLcr) \>=70 mL/minute. CLcr is calculated using the following Cockcroft-Gault formula.
- Male: CLcr = (body weight in kilogram \[kg\] multiplied by \[140 minus age in years\]) divided by (72 multiplied by serum creatinine \[milligram {mg}/deciliter {dL}\]) Female: CLcr = CLcr (male) multiplied by 0.85
- Hemoglobin \>= 8 gram/dL
- WBC \>=1000 per cubic millimeter (mm\^3)
Exclusion
- QTc \> 450 millisecond (msec) or \> 480 msec for subjects with bundle branch block
- Received any interferon or Hepatitis B vaccine therapy within 24 weeks prior to initiation of the study treatment.
- Received overdose of nonsteroidal anti-inflammatory drugs (NSAIDs) (excluding temporary or topical use) within 7 days prior to initiation of the study treatment.
- Received any of the following drugs within 8 weeks prior to initiation of the study treatment (excluding topical products such as ointment and/or cream etc).
- Drugs causing renal impairment (examples: aminoglycosides, amphotericin B, vancomycin, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine, some contrast mediums \[ionic high-osmolar contrast media, ionic low-osmolar contrast media\]
- Competitors of renal excretion (except temporary use, example: probenecid)
- Immunosuppressants (examples: azathioprine, cycolphosphamide) or chemotherapeutics (example: etoposide)
- Glucocorticoid preparation
- Received TDF, Adefovir pivoxil (ADV) or Tenofovir Alafenamide Fumarate (TAF) within 2 years prior to initiation of the study treatment
- Participation in another clinical study within 6 months prior to screening, or planned participation in another clinical study simultaneously with this study.
- Co-infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)
- Subjects with serious complication other than compensated CHB (cancer, significant renal, cardiovascular, pulmonary, or neurological disease, uncontrollable diabetes, etc.)
- Received or have a plan for solid organ or bone marrow transplantation
- Has proximal tubulopathy.
- Subjects with decompensated CHB who meet the following: direct bilirubin \> 1.5 times upper limit of normal (ULN), Prothrombin Time (PT) \< 60%, platelets \< 75,000/mm3 and serum albumin \< 3.0 g/dL
- Autoimmune hepatitis (Antinuclear titer \> 1:160), excluding CHB
- Subjects with or suspected of having hepatocellular carcinoma (HCC) (including both primary and metastatic) from diagnostic imaging at screening, or with serum alpha-fetoprotein (AFP) \> 50 nanogram (ng)/mL at screening
- History of HCC (except subjects who underwent resection or received curative treatment by radiofrequency, and with AFP \<=10 ng/mL at screening)
- Woman who is pregnant, possibly pregnant, lactating or planning a pregnancy during the study period.
- Psychiatry disorder or cognitive disorder that may affect the subject's ability to give informed consent or to follow specified study procedures.
- Subjects with a history of alcohol or drug abuse
- Subjects whom the investigator (or sub-investigator) considers ineligible for the study.
- Subjects with hypersensitivity to study treatments or their components, nucleoside and/or nucleotide analogues. Subjects with drug allergy that, in the investigator's (sub-investigator's) \[or medical monitor's\] opinion, labeled contraindication for participation in the study, or other allergy.
Key Trial Info
Start Date :
October 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2019
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03258710
Start Date
October 2 2017
End Date
November 25 2019
Last Update
August 4 2020
Active Locations (18)
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1
GSK Investigational Site
Aichi, Japan, 467-8602
2
GSK Investigational Site
Chiba, Japan, 270-1694
3
GSK Investigational Site
Ehime, Japan, 790-0024
4
GSK Investigational Site
Ehime, Japan, 790-8524