Chronic Hepatitis b Clinical Trial
Official title:
An Open-Label Phase 2 Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Tenofovir in Naive Patients With Chronic Hepatitis b: a Multicenter, Randomized, Positive Controlled Clinical Trial
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. ;
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