The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection in China.
This study GS-US-320-0108 is an international study planned to enroll participants in global countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study (NCT01940341) before China was able to participate. Therefore, this registration only includes the China cohorts as they were not part of the main study analysis. Data for China cohorts were analyzed separately after the main study analysis was completed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
155
TAF 25 mg tablet administered orally once daily
TDF 300 mg tablet administered orally once daily
TAF placebo tablet administered orally once daily
Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48
Time frame: Week 48
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Time frame: Baseline, Week 48
Percent Change From Baseline in Spine BMD at Week 48
Time frame: Baseline, Week 48
Change From Baseline in Serum Creatinine at Week 48
Time frame: Baseline, Week 48
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TDF placebo tablet administered orally once daily
Peking University First Hospital
Beijing, Beijing Municipality, China
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
The 1st Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi Zhuang, China
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guiyang, China
The 3rd Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tongji Hospital, Tongji Medical college HuaZhong University of Science&Technology
Wuhan, Hubei, China
Nanjing No. 2 Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
...and 19 more locations