A multi-center, randomized, open-label, group controlled study to evaluate the safety and efficacy of T101 combined with nucleoside (acid) analogues in chronic hepatitis B patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients will be injected with T101 once on Day1 (Week0), Day8 (Week1), Day15 (Week2), Day106 (Week15), Day113 (Week16), Day120 (Week17), Day211 (Week30), Day218 (Week31), Day225 (Week32), Day316 (Week45), Day323 (Week46), Day330 (Week47); ETV or TDF will be administrated once each day successively until Day420.
Patients will be injected with T101 once on Day1 (Week0), Day106 (Week15), Day211 (Week30), Day316 (Week45); ETV or TDF will be administrated once each day successively until Day420.
Patients will be administrated ETV or TDF once each day successively until Day420.
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality, China
All the observed or reported AEs (adverse events)
observe and record all the AEs of patients during the clinical trial and determine their correlation with the investigational medical product
Time frame: through study completion, an average of 60 weeks
HBsAg change
evaluate the HBsAg change from the baseline to evaluate the efficacy of T101
Time frame: Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration
The percentage of Subjects' HBsAg decrease ≥ 1 log
to evaluate the efficacy of T101
Time frame: Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration
The percentage of Subjects' HBsAg decrease ≥ 0.5 log
to evaluate the efficacy of T101
Time frame: Day106 (Week15), Day211 (Week30), Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration
Negative convention rate of HBsAg
to evaluate the efficacy of T101
Time frame: Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration
Positive convention rate of HBsAb
to evaluate the efficacy of T101
Time frame: Day316 (Week45), Day337 (Week48), Day421 (Week60) after administration
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Patients will be administrated Peg-IFNα-2b successively once a week until Day330 (Week47); ETV or TDF will be administrated once each day successively until Day420.