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

Last updated: November 12, 2021
Sponsor: Shanghai HEP Pharmaceatical Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT05133856
L47-HB-FIN-1
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. 18 years ≤ age ≤ 60 years, both sexes.
  1. HBsAg (+) or HBV DNA (+) for ≧ 6 months
  2. HBeAg(-)
  3. on stable treatment for NAs for ≧ 2 years.
  4. HBV DNA <LLQD (lower limit of quantitative detection) at screening.
  5. ULN<ALT<10×ULN.
  6. total serum bilirubin <2×ULN.
  7. no childbirth plan within 2 years and agree to take effective contraceptivemeasures throughout the treatment period and within 3 months after the last dose, andthat the woman is not pregnant or breastfeeding.
  8. have not participant in another clinical trial within 3 months
  9. have good compliance with the study protocol.
  10. the subject understands and agrees to sign the informed consent form

Exclusion

Exclusion Criteria:

    1. contraindications to pegylated interferon therapy, such as major depression,epilepsy, autoimmune disease, uncontrolled thyroid abnormal thyroid function, etc.
  1. clinical evidence of cirrhosis: e.g., definite cirrhosis on imaging such asabdominal ultrasound and CT; liver biopsy with Metavir fibrosis score of 4; clinicaldiagnosis of cirrhosis by the investigator.
  2. decompensated liver disease: PT > 1.2 x ULN, serum albumin < 35 g/L
  3. liver function Child-Pugh grade B-C or score >6
  4. any of the following.
  5. history of decompensated liver disease (ascites, hepatic encephalopathy, varicealhemorrhage, hepatorenal syndrome, etc.)
  6. history of severe heart disease (including unstable or uncontrolled heart diseasewithin 6 months)
  7. uncontrolled epilepsy, severe mental illness or history of severe mental illness
  8. history of organ transplantation.
  9. diabetes mellitus and hypertension that are not effectively controlled
  10. autoimmune diseases, immune-related extrahepatic manifestations (vasculitis,purpura, nodular arteritis, peripheral neuropathy and glomerulonephritis) ,thyroid disease, malignancy, and immunosuppressive therapy.
  11. with underlying diseases such as malignancy, severe infections, heart failure andchronic obstructive pulmonary disease, and other serious diseases diseases.
  12. History of alcohol or drug abuse.
  13. creatinine clearance <60mL/min.
  14. co-infected with hepatitis A, C, D or E virus, HIV infection.
  15. subjects who must be treated with anti-HBV nucleoside (acid) analogs other than TAFduring the treatment period.
  16. subjects who have used interferon within 6 months prior to the screening
  17. subjects with positive anti-HBV Pre-S1 antibody.
  18. Abnormal blood tests: white blood cell count < 3×10^9 /L, neutrophil count < 1.5×10^9/L , platelets < 60×10^9 /L .
  19. Positive pregnancy test in women.
  20. patients who are taking drugs prohibited by the test and cannot be discontinued
  21. patients with known allergy to the test drug or the underlying treatment drug
  22. other laboratory or ancillary tests are clearly abnormal and unsuitable forparticipation in the test.

Study Design

Total Participants: 30
Study Start date:
December 01, 2021
Estimated Completion Date:
June 30, 2024

Study 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).

Connect with a study center

  • Shanghai Tong Ren Hospital

    Shanghai, Shanghai 200050
    China

    Site Not Available

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