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

Qilu Pharmaceutical Co., Ltd.2 sites in 1 country100 target enrollmentJuly 26, 2019

ConditionsChronic Hepatitis b

InterventionsTDF tablet QL-007

DrugsTDF tablet QL-007

Overview

Phase: Phase 2
Intervention: TDF tablet
Conditions: Chronic Hepatitis b
Sponsor: Qilu Pharmaceutical Co., Ltd.
Enrollment: 100
Locations: 2
Primary Endpoint: To evaluate the efficacy of QL-007 in combination with TDF in patients with HBeAg-positive chronic hepatitis b: HBV DNA level
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

July 26, 2019

End Date

October 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Qilu Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients aged 18-70 years (inclusive) with chronic HBV infection prior to baseline;
•Positive for HBeAg;
•Patients who had not previously received anti-HBV treatment (including nucleoside or interferon) or had not received antiviral treatment for HBV (including nucleoside or interferon) within 6 months prior to the first taking the study drug;
•HBV DNA≥20,000 IU/mL;
•ALT levels \> upper limit of normal value (ULN) and\<5 times ULN;
•Participants must have understood and signed the ICF.

Exclusion Criteria

•Known co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);
•History of liver disease other than chronic hepatitis B, which may affect the judgment of the effectiveness or safety of the study drug
•History of Gilbert's Disease;
•History of decompensated liver disease or any sign of decompensated liver disease in the screening period;
•Evidence of moderate or severe fibrosis or cirrhosis;
•Evidence of HCC or AFP \> 50 ng / ml in the screening period ;
•Any Clinical laboratory values meet certain standards in the screening period;
•subjects have clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months);
•Risks of serious kidney and respiratory diseases;
•Impaired gastrointestinal (GI) function or GI disease that may alter absorption of QL-007 as determined by the Investigator;

Arms & Interventions

Time Frame: 24 weeks

The change of HBV DNA level at week 24 of treatment compared to baseline

Secondary Outcomes

Virological indexs(96 weeks)
Other evaluation indexes of pharmacodynamics exploration(96 weeks)
To evaluate the tolerance of QL-007 in combination with TDF: incidence of adverse events(96 weeks)
serological indexs(96 weeks)
biochemistry index(96 weeks)