A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D

Exclusion Criteria

• •1\. Subjects suffering from severe decompensated liver fibrosis or decompensated liver cirrhosis with a Child-Pugh score \> 7;
• •2\. Decompensated liver disease: Direct bilirubin \> 1.2 x ULN or prothrombin time \> 1.2 x ULN or serum albumin \< 35 g/L;
• •3\. Abnormal hematology findings: White blood cell count (WBC) \< 3 × 109/L, neutrophil count \< 1.5 × 109/L or platelet count \< 60 × 109/L;
• •4\. Creatinine clearance \< 60 mL/min;
• •5\. Subjects who have any of the following conditions:
• •1. History of current or past decompensated liver diseases (including coagulopathy, hepatic encephalopathy, and variceal bleeding);
• •2. Comorbidity of underlying diseases such as severe infection, heart failure and chronic obstructive pulmonary disease, and other severe diseases;
• •3. Diabetes mellitus and hypertension not effectively controlled (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg);
• •4. Current or previous uncontrolled epilepsy or psychiatric disorders;
• •5. History of solid organ transplantation;
• •6. Evidence of active or suspected malignancies or history of malignancies, or untreated premalignant lesions within the past 5 years (except for successfully treated cervical carcinoma in situ at least 1 year before screening, and successfully treated basal cell carcinoma and squamous cell carcinoma \[≤ 3 cases of resected skin cancer within 5 years before screening \]), or history of liver cancer;
• •7. History of alcohol abuse or drug addiction at present or within 6 months prior to participation in this study; 6. Subjects co-infected with hepatitis A, C, or E virus or with uncontrolled HIV co-infection (those with positive HCV antibody but negative HCV RNA at screening are eligible for enrollment. HIV-infected patients may be enrolled if cluster of differentiation 4 (CD4) cell count is \> 500/mL and HIV RNA is below the limit of detection for at least 12 months);
• •7\. Presence of one or more other known primary or secondary liver diseases, such as alcoholism, autoimmune hepatitis, malignancies involving the liver, hemochromatosis, other congenital or metabolic diseases affecting the liver, congestive heart failure, or other serious cardiopulmonary diseases, excluding hepatitis B;
• •8\. Subjects with one or more autoimmune diseases, immune-related extrahepatic manifestations (such as vasculitis, purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis), or a history of requiring regular use of systemic corticosteroids (inhaled corticosteroids are allowed) or other immunosuppressive agents;
• •9\. Subjects who have used interferon within 6 months before screening;
• •10\. Subjects who have used L47 or Bulevirtide within 3 months;
• •11\. Allergy to entecavir;
• •12\. Pregnant or breastfeeding women;
• •13\. Subjects who participated in other drug clinical trials within 30 days before randomization;
• •14\. Subjects who are receiving prohibited treatment at screening that cannot be discontinued;
• •15\. Subjects who cannot comply with the study protocol and complete all procedures as scheduled, or have significant abnormalities in other laboratory or auxiliary examinations, which render them ineligible for this trial.