Study of Hepalatide in Chronic Hepatitis D(CHD) Patients

Last updated: April 22, 2024
Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Hepatitis

Liver Disorders

Treatment

Hepalatide

Hepalatide Placebo

Clinical Study ID

NCT05827146
L47-HD-IIa
  • Ages 18-65
  • All Genders

Study Summary

A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, 18-65 years old (both inclusive);
  • HBsAg (+) and/or HBV DNA (+) for at least 6 months (clinically diagnosed as "chronichepatitis B");
  • HDV-antibody (IgG/IgM) (+) and HDV RNA (+);
  • 1×ULN <ALT<10×ULN;
  • Patients with hepatitis B eligible to receive treatment with NAs according to currentguidelines for the diagnosis and treatment of hepatitis B;
  • Patients who do not plan a pregnancy within two years (women who are not pregnant orlactating) and agree to take effective contraceptive measures throughout the treatmentperiod and within 3 months after the last dose;
  • Patients who did not participate in any other clinical trials within 3 months;
  • Patients with good compliance with the study protocol;
  • Patients who understand and agree to sign an informed consent form.

Exclusion

Exclusion Criteria:

  • Decompensated liver disease: Direct bilirubin > 1.2× ULN, prothrombin time > 1.2× ULN,and serum albumin < 35 g/L;
  • Patients with abnormal results of routine hematology test: White blood cell count (WBC) < 3×109/L, neutrophil count < 1.5×109/L and platelet count < 60×109/L;
  • Severely decompensated hepatic fiborosis or decompensated cirrhosis: Definitelydiagnosed decompensated cirrhosis by imaging examinations such as a Color Dopplerultrasound and CT of the abdomen or clinically diagnosed decompensated cirrhosis bythe investigator, or a Metavir fibrosis score of 4 on a liver biopsy sample, or aChild-Pugh score > 7 for liver function assessment;
  • Patients who have any of the following conditions:
  1. A history of decompensated liver disease (ascites, jaundice, hepaticencephalopathy, variceal bleeding);
  2. A history of serious cardiovascular disease (including unstable or uncontrolledcardiovascular disease within 6 months);
  3. Serious mental illness or a history of serious mental illness;
  4. A history of organ transplantation;
  5. Uncontrolled epilepsy, mental illness, or poorly controlled diabetes orhypertension;
  6. Autoimmune disease, immune-related extrahepatic manifestations (vasculitis,purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis),thyroid disease, malignant tumor, and receiving immunosuppressive therapy;
  7. Underlying diseases such as severe infection, heart failure, chronic obstructivepulmonary disease, and other severe diseases;
  8. A history of alcohol or drug abuse.
  • Creatinine clearance < 60 mL/min;
  • HAV/HCV/HEV/HIV co-infection;
  • Resistance to or poor response to Entecavir;
  • An allergic reaction to Entecavir;
  • Patients who have used interferon within 3 months before the screening period;
  • Previously received L47 or Bulevirtide;
  • Women who have a positive pregnancy test;
  • Patients who have other significantly abnormal results of laboratory or auxiliarytests and are unsuitable for this trial.

Study Design

Total Participants: 23
Treatment Group(s): 2
Primary Treatment: Hepalatide
Phase: 2
Study Start date:
October 07, 2023
Estimated Completion Date:
February 01, 2024

Study Description

This is a four-arm parallel-group, randomized, placebo-controlled, double-blind, multicenter Phase IIa clinical trial. The CHD subjects who meet the eligibility criteria will be randomly assigned 1:1:1:1 to receive either the placebo or investigational drug (2.1 mg, 4.2 mg, or 6.3 mg), with 6 subjects per group . The placebo or the corresponding dose of the investigational drug will be given for 4 consecutive weeks, followed by a 4-week follow-up period. Subjects will be given entecavir for the treatment of hepatitis B infection during and after the end of the trial.

Connect with a study center

  • The first affiliated hospital of Xinjiang Medical University

    Urumqi, Xinjiang
    China

    Site Not Available

  • The first hospital of Jilin University

    Changchun,
    China

    Site Not Available

  • the National cancer center of Mongolia

    Ulaanbaatar,
    Mongolia

    Site Not Available

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