An Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Tenofovir in Naive Patients With Chronic Hepatitis b

This is an interventional treatment trial for Chronic Hepatitis b focused on measuring HBeAg-positive chronic hepatitis B Read More

Inclusion Criteria:

1. Patients aged 18-70 years (inclusive) with chronic HBV infection prior to baseline;
2. Positive for HBeAg;
3. 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;
4. HBV DNA≥20,000 IU/mL;
5. ALT levels > upper limit of normal value (ULN) and<5 times ULN;
6. Participants must have understood and signed the ICF.

Exclusion Criteria:

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

11. Receiving medications that meet one of the following criteria and that cannot be discontinued ≥1 week prior to the start of treatment QL-007:

    • Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes;
    • Moderate or strong inhibitors or strong inducers of CYP3A4
12. Intake of any drugs that can reduce enzyme activity;
13. History of bleeding diathesis;
14. Risks of mental and nervous system diseases during screening;
15. Pregnant or lactating female subjects; Female subjects of childbearing age who were not willing to use effective contraception throughout the study period or male subjects whose partners were fertile but were not willing to use effective contraception;
16. Volunteers who took an Investigational Product within 3 months or who have been within 5 half-lives of other trial drugs before the randomization.
17. Any other condition , which in the opinion of investigator would make a patient unfit for participation in a clinical study.