Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D

Inclusion criteria

• Positive HBsAg or HBV DNA for at least 6 months (diagnosed as chronic hepatitis B), with stable nucleos(t)ide analogue (NA) treatment for ≥3 months prior to screening and documented HBV DNA suppression;
• Positive anti-HDV antibody (IgG and/or IgM) and at least two quantifiable HDV RNA measurements ≥3 months apart, with quantifiable HDV RNA at enrollment;
• 1×ULN< ALT<10×ULN；
• No plan for pregnancy within 2 years; female subjects must not be pregnant or lactating, and all subjects must agree to use effective contraception during treatment and for 3 months after the last dose;
• No participation in other clinical trials within 3 months prior to screening;
• Good compliance with the study protocol;
• Ability to understand and willingness to sign the informed consent form (ICF).

Exclusion criteria

• Child-Pugh class C or Child-Pugh score ≥10;
• Subjects with any of the following conditions:

• History of severe decompensated liver disease, including moderate to severe ascites (grade 2 or 3), hepatic encephalopathy, gastrointestinal variceal bleeding, hepatorenal syndrome, etc., with an expected survival of less than 2 years;
• History of severe cardiac disease (including unstable or uncontrolled heart disease within the past 6 months, or New York Heart Association [NYHA] functional class III-IV);
• Uncontrolled epilepsy, severe psychiatric disorders, or a history of severe psychiatric disorders;
• History of organ transplantation;
• Diabetes mellitus or hypertension that is not adequately controlled;
• Presence of autoimmune diseases, immune-related extrahepatic manifestations (including vasculitis, purpura, polyarteritis nodosa, peripheral neuropathy, and glomerulonephritis), thyroid diseases, malignancies, or receipt of immunosuppressive therapy;
• Presence of serious underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, or other serious diseases;
• History of alcohol abuse or drug addiction.
• Total bilirubin > 51 μmol/L, or serum albumin < 28 g/L, or prothrombin time prolonged by > 6 seconds;
• Creatinine clearance<60mL/min；
• Co-infection with hepatitis A, C, or E virus, or HIV infection;
• Use of interferon within 3 months prior to screening;
• Positive pregnancy test in female subjects;
• Abnormal hematology results: white blood cell count (WBC) < 3×10^9/L, neutrophil count 1.5×10^9/L, or platelet count 60×10^9/L；
• Current use of prohibited medications that cannot be discontinued;
• Use of L47 or Myrcludex B within 3 months prior to screening;
• Subjects receiving standardized nucleos(t)ide analogue (NA) therapy with a treatment duration of less than 12 weeks;
• Other significant abnormalities in laboratory tests or auxiliary examinations that, in the opinion of the investigator, make the subject unsuitable for participation in this study.