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

Chronic Hepatitis b Clinical Trial

— Neptune  

Official title:

New Combination of ETV, TQ-A3334 and TQ-B2450 for the Treatment of Chronic Hepatitis B Virus Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04202653
• Other study ID #: TQ-A3334-II-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2019
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ETV
entecavir 0.5 mg qd
• TQ-A3334
TQ-A3334 po qw
• TQ-B2450
TQ-B2450 q3w iv

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HBsAg quantification at week 24	HBsAg quantification are measured	week 24
Secondary	HBsAg loss rates at week 24	HBsAg loss rates are measured	week 24
Secondary	HBsAg seroconversion rates at week 24	HBsAg seroconversion rates are measured	week 24
Secondary	HBeAg loss rates at week 24	HBeAg loss rates are measured	week 24
Secondary	HBeAg seroconversion rates at week 24	HBeAg seroconversion rates are measured	week 24
Secondary	HBV DNA<20IU/mL rates at week 24	HBV DNA<20IU/mL rates are measured	week 24