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)-positive chronic hepatitis B virus (HBV) infection in China.
This study GS-US-320-0110 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 (NCT01940471) 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
181
TAF 25 mg tablet administered orally once daily
TDF 300 mg tablet administered orally once daily
TAF placebo tablet administered orally once daily
Beijing Ditan Hospital
Beijing, China
Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48
Time frame: Week 48
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) 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 at Week 48 in Serum Creatinine
Time frame: Baseline; Week 48
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TDF placebo tablet administered orally once daily
PLA 302 Hospital
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
Xianya Hospital, Central South University
Changsha, China
Guangzhou Eighth People's Hospital
Guangzhou, China
Nanfang Medical University, Nanfang Hospital
Guangzhou, China
No. 3 Hospital, Zhongshan Medical University
Guangzhou, China
The Affiliated Hospital of Guiyang Medical College
Guiyang, China
The People's Hospital of Hainan Province
Haikou, China
...and 15 more locations