A Study of TAF in Combination With PEG-IFN and Hepalatide in Subjects With Chronic Hepatitis B

Status and phase: Not yet enrolling; Phase 2

Conditions: Chronic; Hepatitis B

Study type: Interventional

Funder types: Industry

Identifiers

NCT05133856

L47-HB-FIN-1

Details and patient eligibility

About

The study is designed to assess efficacy of hepalatide in Combination with Pegylated Interferon and TAF compared to Pegylated Interferon in Combination with TAF in patients with Chronic Hepatitis B .Subjects will be randomly assigned to the hepalatide or placebo groups , 15 subjects in each group . Subjects will receive hepalatide+Pegylated Interferon +TAF treatment for 48 weeks or placebo +Pegylated Interferon +TAF treatment for 48 weeks , followed by a safety follow-up for 24 weeks.

Full description

Hepalatide is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection. Pegylated interferon and TAF are approved drugs for the treatment of chronic HBV infection . The primary hypothesis of this study is that combination regimen of hepalatide+NA+Pegylated interferon is more efficacious than NA+Pegylated interferon treatment , as measured by the primary efficacy endpoint. This study will be conducted in 3 periods: Screening Period (4weeks), Treatment Period (48 weeks) and Follow-up (FU) Period (24 weeks). Safety assessments will include adverse events (AEs), serious AEs, clinical safety laboratory tests, electrocardiograms (ECGs), vital signs, ophthalmologic examinations and physical examinations. Total duration of individual participation will be up to 76 weeks (including screening period).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years ≤ age ≤ 60 years, both sexes.

2. HBsAg (+) or HBV DNA (+) for ≧ 6 months

3. HBeAg(-)

4. on stable treatment for NAs for ≧ 2 years.

5. HBV DNA <LLQD (lower limit of quantitative detection) at screening.

6. ULN<ALT<10×ULN.

7. total serum bilirubin <2×ULN.

8. no childbirth plan within 2 years and agree to take effective contraceptive measures throughout the treatment period and within 3 months after the last dose, and that the woman is not pregnant or breastfeeding.

9. have not participant in another clinical trial within 3 months

10. have good compliance with the study protocol.

11. the subject understands and agrees to sign the informed consent form

Exclusion criteria

1. contraindications to pegylated interferon therapy, such as major depression, epilepsy, autoimmune disease, uncontrolled thyroid abnormal thyroid function, etc.

2. clinical evidence of cirrhosis: e.g., definite cirrhosis on imaging such as abdominal ultrasound and CT; liver biopsy with Metavir fibrosis score of 4; clinical diagnosis of cirrhosis by the investigator.

3. decompensated liver disease: PT > 1.2 x ULN, serum albumin < 35 g/L

4. liver function Child-Pugh grade B-C or score >6

5. any of the following.

history of decompensated liver disease (ascites, hepatic encephalopathy, variceal hemorrhage, hepatorenal syndrome, etc.) history of severe heart disease (including unstable or uncontrolled heart disease within 6 months) uncontrolled epilepsy, severe mental illness or history of severe mental illness history of organ transplantation. diabetes mellitus and hypertension that are not effectively controlled autoimmune diseases, immune-related extrahepatic manifestations (vasculitis, purpura, nodular arteritis, peripheral neuropathy and glomerulonephritis) , thyroid disease, malignancy, and immunosuppressive therapy. with underlying diseases such as malignancy, severe infections, heart failure and chronic obstructive pulmonary disease, and other serious diseases diseases. History of alcohol or drug abuse.

6. creatinine clearance <60mL/min.

7. co-infected with hepatitis A, C, D or E virus, HIV infection.

8. subjects who must be treated with anti-HBV nucleoside (acid) analogs other than TAF during the treatment period.

9. subjects who have used interferon within 6 months prior to the screening

10. subjects with positive anti-HBV Pre-S1 antibody.

11. Abnormal blood tests: white blood cell count < 3×10^9 /L, neutrophil count < 1.5×10^9/L , platelets < 60×10^9 /L .

12. Positive pregnancy test in women.

13. patients who are taking drugs prohibited by the test and cannot be discontinued

14. patients with known allergy to the test drug or the underlying treatment drug

15. other laboratory or ancillary tests are clearly abnormal and unsuitable for participation in the test.