This is an open label, randomized, multi-center, comparative study. Subjects will be screened prior to study entry to establish eligibility. 100 Subjects who meet all the selection criteria will be randomly assigned 1:1:1:1:1 to (A) QL007 100 mg QD+ Tenofovir dipirofurate fumarate (TDF)300 mg QD, (B) QL007 200 mg QD+ TDF 300 mg QD, (C) QL007 400 mg QD+ TDF 300 mg QD, (D) QL007 200 mg BID+ TDF 300 mg QD, (E) TDF 300 mg QD. The purpose of this study was to evaluate the efficacy and safety of QL-007 in combination with TDF in HBeAg positive patients with chronic hepatitis b, and to recommend a reasonable regimen for phase III study.
The subjects received the drug treatment for a total of 96 weeks, which was divided into two stages: the first stage: 0-24 weeks as the core treatment period and 25-48 weeks as the extended treatment period. The second stage: 49-96 weeks is the extended treatment period,subjects will enter the second stage of treatment according to the dose of the first stage. When the efficacy data of the first phase determine the optimal dose of QL-007, all subjects entering the second phase will receive the optimal dose of QL-007 and continue treatment with tenofovir dipirofurate fumarate (QL-007 XX mg+TDF) for the second phase 49-96 weeks of extended treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
TDF tablet 300mg QD
QL-007 tablet
Southern Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGThe first hospital of Jilin university
Changchun, Jilin, China
RECRUITINGTo evaluate the efficacy of QL-007 in combination with TDF in patients with HBeAg-positive chronic hepatitis b: HBV DNA level
The change of HBV DNA level at week 24 of treatment compared to baseline
Time frame: 24 weeks
serological indexs
The changes of HBsAg and HBeAg level from baseline at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96
Time frame: 96 weeks
serological indexs
The percentage of subjects with HBsAg and HBeAg serological clearance and/or seroconversion at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96
Time frame: 96 weeks
Virological indexs
The changes of HBV DNA level compared to baseline at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96
Time frame: 96 weeks
Virological indexs
The rate of HBV DNA negative subjects (HBV DNA \<60 IU/mL) at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96
Time frame: 96 weeks
biochemistry index
The changes of ALT at week 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96 compared to baseline
Time frame: 96 weeks
biochemistry 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 level 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 tolerance of QL-007 in combination with TDF: incidence of adverse events
The incidence of adverse events
Time frame: 96 weeks
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