Clinical trial NCT04202653: Combination of ETV, TQ-A3334 and TQ-B2450 for CHB (Neptune Study)
Official title: New Combination of ETV, TQ-A3334 and TQ-B2450 for the Treatment of Chronic Hepatitis B Virus Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Hepatitis b
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
First posted: 2019-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in HBsAg quantification at week 24
timeFrame: week 24
Secondary outcomes:
measure: HBsAg loss rates at week 24
timeFrame: week 24
measure: HBsAg seroconversion rates at week 24
timeFrame: week 24
measure: HBeAg loss rates at week 24
timeFrame: week 24
measure: HBeAg seroconversion rates at week 24
timeFrame: week 24
measure: HBV DNA<20IU/mL rates at week 24
timeFrame: week 24
Other outcomes:
Locations:
Study officials:
References: