New hope for hepatitis d: experimental drug enters final testing phase

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. 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; 2. 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); 3. Uncontrolled epilepsy, severe psychiatric disorders, or a history of severe psychiatric disorders; 4. History of organ transplantation; 5. Diabetes mellitus or hypertension that is not adequately controlled; 6. 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; 7. Presence of serious underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, or other serious diseases; 8. 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.