A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients

Last updated: July 11, 2024
Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Hepatitis

Liver Disorders

Hepatitis B

Treatment

Placebo of Hepalatide

Tenofovir Alafenamide Tablets

Pegylated Interferon alfa 2a

Clinical Study ID

NCT05244057
L47-HB-FIN-1(New Finite)
  • Ages 18-60
  • All Genders

Study Summary

The study is designed to assess efficacy of a finitie treatment in Chronic Hepatitis B patients who had stable treatment of NAs for ≧ 2 years, which is compared hepalatide in combination with Pegylated Interferon + TAF with Pegylated Interferon +TAF. 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 +PegylatedInterferon +TAF treatment for 48 weeks , Then, stopping hepalatide and Pegylate Interferon treatments and followed with further 8 weeks follow-up.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. HBsAg or/and HBV DNA Positive for at least 6 months

  2. HBeAg negative

  3. Received NAs stabilization therapy for at least 2 years

  4. ALT≤ 2×ULN

  5. HBV DNA< LLQD(lower limit of quantitative detection) in Screening

  6. Serum total 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 lastdose, and that the woman is not pregnant or breastfeeding.

  8. have not participant in another clinical trial within 3 months before screening

  9. Subjects have good compliance with the protocol

  10. Subjects understood and agreed to sign the informed consent form.

Exclusion

Exclusion Criteria:

  1. Contraindications of Peginterferon such as depressive disorder, epilepsy,autoimmune diseases, uncontrolled thyroid dysfunction, etc

  2. Subjects with cirrhosis, e.g., definite cirrhosis on imaging such as abdominalultrasound and CT; liver biopsy with Metavir fibrosis score = 4; clinicaldiagnosis of cirrhosis by the investigator.

  3. Decompensated liver disease

  4. Child-Pugh score of B-C or over 6 points.

  5. Subjects with any of the following circumstances

  • History of decompensated liver disease

  • History of serious heart disease (including unstable or uncontrolled heart diseasewithin 6 months)

  • Uncontrolled seizures, severe psychiatric disorders, or a history of psychiatricdisorders

  • with history of organ transplantation

  • with poorly controlled diabetes and hypertension

  • with autoimmune diseases, immune-related extrahepatic manifestations, thyroiddisease, malignant tumors, or in immunosuppressive therapy

  • underlying diseases such as malignant tumor, severe infection, heart failure andchronic obstructive pulmonary disease and other serious diseases.

  • with history of alcohol or drug abuse

  1. Creatinine clearance <60 mL/min.

  2. HAV, HCV, HDV, HEV or HIV co-infection

  3. Subjects who must be treated with Nucleosides (acids) other than TAF duringtreatment period

  4. Subjects who used interferon in the 6 months prior to the screening period

  5. Positive for anti-HBV Pre-S1 antibody.

  6. Hemocytopenia: White blood cells < 3 × 10^9 / L, neutrophil < 1.5 × 10^9 / L,platelet < 60 × 10^9 / L,

  7. Female subjects pregnancy test positive

  8. known to be allergic to the investigational drug or the underlying treatmentdrug

  9. Other laboratories or auxiliary examinations are obviously abnormal

Study Design

Total Participants: 8
Treatment Group(s): 4
Primary Treatment: Placebo of Hepalatide
Phase: 2
Study Start date:
August 23, 2022
Estimated Completion Date:
June 24, 2024

Study Description

Hepalatide is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection. The aim of this study is to assess efficacy of a finitie treantment , that combination regimen of hepalatide+half dose Pegylated interferon + TAF , 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 (8 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 60 weeks (including screening period).

Connect with a study center

  • Shanghai East Hospital

    Shanghai, Shanghai 200127
    China

    Site Not Available

  • Shanghai Tong Ren Hospital

    Shanghai, Shanghai 200050
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.