Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT04157257
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged 18-70 years (inclusive) with chronic HBV infection prior to baseline;
2. Subjects who have received a entecavir or tenofovir ester treatment for more than 1 year before screening ;
3. HBsAg \> 250 IU/mL and HBV DNA \< 60 IU/mL at screening period;
4. ALT≤ 2×ULN;
5. Participants must have understood and signed the ICF.
Exclusion Criteria:
1. Confirmed 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;
3. History of Gilbert's Disease;
4. History of decompensated liver disease or any sign of decompensated liver disease at the screening period;
5. Evidence of moderate or severe fibrosis or cirrhosis;
6. Evidence of HCC or AFP \> 50 ng/ml at the screening period.
7. Any Clinical laboratory values meet the certain standards at the screening period;
8. Subjects have clinically significant, uncontrolled heart disease and/or recent cardiac event;
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04157257
Study Brief:
Protocol Section:
NCT04157257