Study of Hepalatide in Chronic Hepatitis D(CHD) Patients
Chronic Hepatitis D Infection
About this trial
This is an interventional treatment trial for Chronic Hepatitis D Infection focused on measuring chronic hepatitis D, hepalatide, hepatitis D virus
Eligibility Criteria
Inclusion Criteria: Male or female, 18-65 years old (both inclusive); HBsAg (+) and/or HBV DNA (+) for at least 6 months (clinically diagnosed as "chronic hepatitis 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 current guidelines for the diagnosis and treatment of hepatitis B; Patients who do not plan a pregnancy within two years (women who are not pregnant or lactating) and agree to take effective contraceptive measures throughout the treatment period 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 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; Severe liver fibrosis or cirrhosis: Definitely diagnosed liver cirrhosis by imaging examinations such as a Color Doppler ultrasound and CT of the abdomen or clinically diagnosed liver cirrhosis by the investigator, or a Metavir fibrosis score of 4 on a liver biopsy sample, or a Child-Pugh score > 7 for liver function assessment; Patients who have any of the following conditions: A history of decompensated liver disease (ascites, jaundice, hepatic encephalopathy, variceal bleeding); A history of serious cardiovascular disease (including unstable or uncontrolled cardiovascular disease within 6 months); Serious mental illness or a history of serious mental illness; A history of organ transplantation; Uncontrolled epilepsy, mental illness, or poorly controlled diabetes or hypertension; Autoimmune disease, immune-related extrahepatic manifestations (vasculitis, purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis), thyroid disease, malignant tumor, and receiving immunosuppressive therapy; Underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, and other severe diseases; 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 auxiliary tests and are unsuitable for this trial.
Sites / Locations
- The first hospital of Jilin University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Hepalatide 2.1mg
Hepalatide 4.2mg
Hepalatide 6.3mg
Placebo 2.1mg/4.2mg/6.3mg
2.1 mg/day subcutaneously (s.c.) for 4 week
4.2 mg/day subcutaneously (s.c.) for 4 week
6.3 mg/day subcutaneously (s.c.) for 4 week
Placebo 2.1 mg/4.2mg/6.3mg, once a day subcutaneously (s.c.) for 4 week