Phase
Condition
Hepatitis B
Hepatitis
Liver Disorders
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients aged 18-70 years (inclusive) with chronic HBV infection prior to baseline;
Subjects who have received a entecavir or tenofovir ester treatment for more than 1year before screening ;
HBsAg > 250 IU/mL and HBV DNA < 60 IU/mL at screening period;
ALT≤ 2×ULN;
Participants must have understood and signed the ICF.
Exclusion
Exclusion Criteria:
Confirmed 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;
History of Gilbert's Disease;
History of decompensated liver disease or any sign of decompensated liver disease atthe screening period;
Evidence of moderate or severe fibrosis or cirrhosis;
Evidence of HCC or AFP > 50 ng/ml at the screening period.
Any Clinical laboratory values meet the certain standards at the screening period;
Subjects have clinically significant, uncontrolled heart disease and/or recent cardiacevent;
Risks of serious kidney and respiratory diseases;
Impaired gastrointestinal (GI) function or GI disease that may alter absorption ofQL-007 as determined by the Investigator;
Receiving medications that meet one of the following criteria and that cannot bediscontinued ≥1 week prior to the start of treatment QL-007:
Medication with a known risk of prolonging the QT interval or inducing Torsadesde Pointes;
Moderate or strong inhibitors or strong inducers of CYP3A4
Intake of any drugs that can reduce enzyme activity;
History of bleeding diathesis;
Risks of mental and nervous system diseases during screening;
Pregnant or lactating female subjects; Female subjects of childbearing age who werenot willing to use effective contraception throughout the study period or malesubjects whose partners were fertile but were not willing to use effectivecontraception;
Volunteers who took an Investigational Product within 3 months or who have been within 5 half-lives of other trial drugs before the randomization;
Any other condition , which in the opinion of investigator would make a patient unfitfor participation in a clinical study.
Study Design
Study Description
Connect with a study center
Southern Hospital of Southern Medical University
Guangzhou, Guangdong 510000
ChinaActive - Recruiting
The first hospital of jilin university
Changchun, Jilin 130000
ChinaActive - Recruiting

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