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CompletedNCT05244057Updated Jul 15, 2024

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

A Phase 2 interventional study of Hepalatide and Placebo of Hepalatide in Chronic Hepatitis B, sponsored by Shanghai HEP Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Shanghai HEP Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

Read the detailed 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).

02

Conditions studied

  • Chronic Hepatitis B

Keywords

  • hepalatide, Hepatitis B,finite treatment,
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

      1. HBeAg negative
      1. Received NAs stabilization therapy for at least 2 years
      1. ALT≤ 2×ULN
      1. HBV DNA\< LLQD(lower limit of quantitative detection) in Screening
      1. Serum total bilirubin\<2×ULN
      1. 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.
      1. have not participant in another clinical trial within 3 months before screening
      1. Subjects have good compliance with the protocol
      1. Subjects understood and agreed to sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

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

      1. Subjects with cirrhosis, e.g., definite cirrhosis on imaging such as abdominal ultrasound and CT; liver biopsy with Metavir fibrosis score = 4; clinical diagnosis of cirrhosis by the investigator.
      1. Decompensated liver disease
      1. Child-Pugh score of B-C or over 6 points.
      1. Subjects with any of the following circumstances
  • History of decompensated liver disease
  • History of serious heart disease (including unstable or uncontrolled heart disease within 6 months)
  • Uncontrolled seizures, severe psychiatric disorders, or a history of psychiatric disorders
  • with history of organ transplantation
  • with poorly controlled diabetes and hypertension
  • with autoimmune diseases, immune-related extrahepatic manifestations, thyroid disease, malignant tumors, or in immunosuppressive therapy
  • underlying diseases such as malignant tumor, severe infection, heart failure and chronic obstructive pulmonary disease and other serious diseases.
  • with history of alcohol or drug abuse

    1. Creatinine clearance \<60 mL/min.
    1. HAV, HCV, HDV, HEV or HIV co-infection
    1. Subjects who must be treated with Nucleosides (acids) other than TAF during treatment period
    1. Subjects who used interferon in the 6 months prior to the screening period
    1. Positive for anti-HBV Pre-S1 antibody.
    1. Hemocytopenia: White blood cells \< 3 × 10\^9 / L, neutrophil \< 1.5 × 10\^9 / L, platelet \< 60 × 10\^9 / L,
    1. Female subjects pregnancy test positive
    1. known to be allergic to the investigational drug or the underlying treatment drug
    1. Other laboratories or auxiliary examinations are obviously abnormal
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Hepalatide + TAF + PEG-IFN

    Patients will receive 6.3mg Hepalatide +25mg Tenofovir alafenamide+ 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.

    Drug: Hepalatide · Drug: Tenofovir Alafenamide Tablets · Drug: Pegylated Interferon alfa 2a

  • Placebo comparator
    Placebo+ TAF + PEG-IFN

    Patients will receive Placebo +25mg Tenofovir alafenamide + 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.

    Drug: Placebo of Hepalatide · Drug: Tenofovir Alafenamide Tablets · Drug: Pegylated Interferon alfa 2a

Interventions

  • DrugHepalatide

    6.3mg, s.c., qd for 48 weeks

    Also known as: L47

  • DrugPlacebo of Hepalatide

    s.c., qd for 48 weeks

    Also known as: Placebo

  • DrugTenofovir Alafenamide Tablets

    25mg, p.o., qd for 48 weeks

    Also known as: Vemlidy

  • DrugPegylated Interferon alfa 2a

    90ug, s.c., qw for 48 weeks

    Also known as: Pegasys

05

What researchers measure

Primary outcomes

  1. Proportion of subjects with negative conversion of HBsAg

    Proportion of subjects with negative conversion of HBsAg treatment at 8 weeks off treatment

    Time frame: 56 Weeks

Secondary outcomes

  1. Number of subjects with virological relapse(VR) at 8 weeks off treatment

    VR: reappearance of HBV DNA \> 2000 IU/ml from undetectable status

    Time frame: 56 Weeks

  2. Number of subjects with clinical relapse(CR) at 8 weeks off treatment

    CR: the presence of VR with the elevation of alanine transaminase (ALT) more than two times upper limit of normal (ULN)

    Time frame: 56 Weeks

  3. HBsAg is down from baseline at 8 weeks off treatment

    HBsAg is down from baseline log10

    Time frame: 56 Weeks

  4. Number of subjects with Serological conversion of HBsAg

    Number of subjects with Serological conversion of HBsAg at 8 weeks off treatment

    Time frame: 56 Weeks

  5. Change in liver stiffness at 8 weeks off treatment

    The findings of Liver stiffness measurement(LSM) of Fibroscan/FibroTouch at week 8 off treatment compared to baseline

    Time frame: 56 Weeks

06

Study locations

1 site
  • Shanghai Tong Ren Hospital
    Shanghai, Shanghai 200050, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05244057
Lead sponsor
Shanghai HEP Pharmaceutical Co., Ltd.
Collaborators
Shanghai Tong Ren Hospital, Shanghai East Hospital
Responsible party
Sponsor
First posted
Feb 17, 2022
Start date
Aug 23, 2022
Primary completion
Jun 24, 2024
Completion
Jun 24, 2024
Last update
Jul 15, 2024

Study contacts

Qin Zhang
principal investigator · Shanghai Tong Ren Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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