This is an open label, randomized, multi-center, comparative study. Subjects will be screened prior to study entry to establish eligibility. 60 Subjects who meet all the selection criteria will be randomly assigned to (A) QL007 200mg BID+ Tenofovir dipirofurate fumarate (TDF)300 mg QD, (B) QL007 200 mg BID+ Entecavir 0.5 mg QD, (C)TDF 300 mg QD, (D) Entecavir 0.5 mg QD. The purpose of this study was to evaluate the efficacy and safety of QL-007 tables in combination with TDF or Entecavir in patients with chronic hepatitis b who have received nucleoside (acid) therapy, and to recommend a reasonable regimen for phase III study.
The subjects received the drug treatment for a maximum of 96 weeks: divided into two stages: the first stage: 0-24 weeks as the core treatment period, 25-48 weeks as the extended treatment period. The second stage: 49-96 weeks is the extended treatment period. Stage 2: subjects in stage 1 group A and C were grouped into group E(QL-007 200 mg BID或XX mg +TDF 300 mg QD), and subjects in group B and D were grouped into group F(QL-007 200 mg BID或XX mg + Entecavir 0.5 mg QD). Subjects in group E and F entered the second stage of treatment according to 200 mg BID. After the efficacy data of the original treatment clinical trial (protocol 201) determine the optimal dose of 007, all subjects entering the second phase will receive the optimal dose of 007 and continue treatment withTDF or Entecavir tablets (007 XXmg+TDF or ETV) into the second phase 49-96 weeks of extended treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
TDF tablet 300mg QD
Entecavir tablet 0.5mg QD
QL-007 tablets 200mg BID
Southern Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGThe first hospital of jilin university
Changchun, Jilin, China
RECRUITINGMain index of pharmacodynamics
The change of HBsAg levels at week 24 compared to baseline
Time frame: 24 weeks
The secondary pharmacodynamic index
The changes of HBsAg and HBeAg level at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96 compared to baseline
Time frame: 96 weeks
The secondary pharmacodynamic index
The percentage of subjects with HBsAg and HBeAg serological clearance and/or seroconversion at 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96 weeks
Time frame: 96 weeks
The secondary pharmacodynamic index
The percentage of subjects with normal ALT level at weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84 and 96
Time frame: 96 weeks
Other evaluation indexes of pharmacodynamics exploration
The changes of HBV RNA and HBcrAg compared with baseline at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84 and 96
Time frame: 96 weeks
To evaluate the safety of QL-007 in combination with TDF or Entecavir: incidence of adverse events
The incidence of adverse events
Time frame: 96 weeks
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