A Phase 4 interventional study of Thymosin Alpha1 and Entecavir in Chronic Hepatitis b, sponsored by Wen-hong Zhang. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Wen-hong Zhang · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
thymosin alpha 1 (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
Drug: Thymosin Alpha1 · Drug: Entecavir
ETV (0.5 mg orally, daily) at least for 72 weeks
Drug: Entecavir
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
HBeAg 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
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
Plan to share: No
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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Wen-hong Zhang