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

Tongji Hospital

Status and phase: Unknown; Phase 2

Conditions: Chronic Hepatitis b

Treatments: Drug: TQ-B2450; Drug: ETV; Drug: TQ-A3334

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04202653

TQ-A3334-II-02

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 6 patient groups

Naive:ETV

Active Comparator group

Description:

Entecavir 0.5 mg po daily for 24 weeks in naive patients

Treatment:

Drug: ETV

Naive:ETV+TQ-A3334

Experimental group

Description:

Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in naive patients

Treatment:

Drug: ETV

Drug: TQ-A3334

Naive:ETV+TQ-A3334+TQ-B2450

Experimental group

Description:

Entecavir 0.5 mg po daily plus TQ-A3334 plus inhibitor of TQ-B2450 for 24 weeks in naive patients

Treatment:

Drug: ETV

Drug: TQ-A3334

Drug: TQ-B2450

Experienced:ETV

Active Comparator group

Description:

Entecavir 0.5 mg po daily for 24 weeks in treatment experienced patients

Treatment:

Drug: ETV

Experienced:ETV+TQ-A3334

Experimental group

Description:

Entecavir 0.5 mg po daily plus TQ-A3334 for 24 weeks in treatment experienced patients

Treatment:

Drug: ETV

Drug: TQ-A3334

Experienced:ETV+TQ-A3334+TQ-B2450

Experimental group

Description:

Entecavir 0.5 mg po daily plus TQ-A3334 plus TQ-B2450 for 24 weeks in treatment experienced patients

Treatment:

Drug: ETV

Drug: TQ-A3334

Drug: TQ-B2450