Combination of ETV, TQ-A3334 and TQ-B2450 for CHB (Neptune Study)

• Status: Not yet recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is a single-center, randomized, prospective, open-label Phase 2 Clinical trial to evaluate efficacy and safety of ETV and TQ-A3334 combinated with/without inhibitor of TQ-B2450 versus ETV alone in chronic hepatitis B patients. Patients were randomized to one of 3 different antiviral treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tongji Hospital
• Collaborator: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Criteria

Inclusion Criteria:

1. Male and female patients from 18 to 65 years of age;

2. Chronic hepatitis B infection

3. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug;

4. Agree to participate in the study and sign the patient informed consent.

Exclusion Criteria:

1. Patients who had NAs resistance;

2. Other antiviral, anti-neoplastic or immunomodulatory treatment;

3. Women with ongoing pregnancy or breast-feeding;

4. Co-infection with active hepatitis A, hepatitis C, hepatitis D(Those hospitals which have the ability to do the test will do) and/or human immunodeficiency virus (HIV);

5. ALT >10 ULN;

6. LSM >9kPa ;

7. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);

8. Signs or symptoms of hepatocellular carcinoma;

9. Neutrophil count < 1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening;

10. Hemoglobin < 11.5 g/dL for females and <12.5 g/dL for men;

11. Serum creatinine level > 1.5 ULN in screening period.

12. Phosphorus < 0.65 mmol/L;

13. ANA > 1:100;

14. History of severe psychiatric disease;

15. History of a severe seizure disorder or current anticonvulsant use;

16. History of immunologically mediated disease, (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.);

17. History of chronic pulmonary disease associated with functional limitation;

18. Diseases that IFN and Nucleotides or nucleosides are not suitable.