The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV) vaccine (mimogen-based)) Joint entecavir treatment in chronic hepatitis B patients.
Eligible subjects are enrolled and assigned into 2 groups randomly with a 1:1 ratio: 1. Therapeutic HBV vaccine Joint Entecavir group:Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day ; 2. Empty liposome Joint Entecavir group:Inject empty liposome at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day. The study cycle consists of screening and enrollment period (week -4~0), treatment and follow-up period (week 0-96).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
378
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
0.5mg,per day,oral intake.
Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
The First Affiliated of Anhui Medical University
Hefei, Anhui, China
Beijing Youan Hosptial,Capital Medical University
Beijing, Beijing Municipality, China
The Third People's Hosptial of Shenzhen
Percentage of Participants With HBeAg Seroconversion at Week 48
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
Time frame: 48 weeks
Serological Response
Serological response at every observation time: serological conversion rate of HBeAg, negative conversion rate of HBeAg, and change of HBeAg.
Time frame: 96 weeks
Virological Response
Virological response at every observation time: the proportion of patients with serum HBV DNA level reduction to undetectable level, decreased amount of serum HBV DNA compared with the baseline value, and HBV DNA load decrease 2 log scales or HBV DNA level \<1.72×104 IU/ml.
Time frame: 96 weeks
Biochemistry Response
Biochemistry response at every observation time, mean the ALT level reduce to normal.
Time frame: 96 weeks
Histological Response
Histological response at week 72, mean histological score limited reduce 2 (reduced score 2-5), and no fiber deterioration compare with before treatment.
Time frame: 72 weeks
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Shenzhen, Guangdong, China
Renmin Hosptial of Wuhan University
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
81th Hospital of PLA
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
TangDu Hospital
XiAn, Shanxi, China
...and 5 more locations