This is a multicenter, randomized, open-label control trial of two arms conducted at 10 centres in China.The aim was to investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 2 years), and to select the optimal patients who may benefit from sequential combination therapy.
To investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 1 years), and to select the optimal patients who may benefit from sequential combination therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
Thymosin Alpha1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks
ETV (0.5 mg orally, daily) for 72 weeks
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGHBeAg seroconversion rate at week 72
HBeAg seroconversion rate at week 72
Time frame: week 72
HBeAg seroconversion rate at week 48
HBeAg seroconversion rate at week 48
Time frame: week 48
HBsAg loss at week 48
HBsAg loss at week 48
Time frame: week 48
HBsAg loss at week 72
HBsAg loss at week 72
Time frame: week 72
HBsAg seroconversion at week 72
HBsAg seroconversion at week 72
Time frame: week 72
HBsAg seroconversion at week 48
HBsAg seroconversion at week 48
Time frame: week 48
HBsAg decline during the clinical trial
HBsAg decline during the clinical trial
Time frame: week 12, weeek 24, week 36, week 48 and week 72
ALT normalization rate at week 72
ALT normalization rate at week 72
Time frame: week 72
ALT normalization rate at week 48
ALT normalization rate at week 48
Time frame: week 48
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Rate of HBV DNA <20IU/mL at week 72
Rate of HBV DNA \<20IU/mL at week 72
Time frame: week 72
Rate of HBV DNA <20IU/mL at week 48
Rate of HBV DNA \<20IU/mL at week 48
Time frame: week 48