Chronic hepatitis D
Conditions
Interventions
L47 2.1mg Group:L47 2.1mg QD+ ETV 0.5mg QD
Placebo Group:ETV 0.5mg QD
Sponsors
Jilin University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 65 years old (inclusive), both males and females are eligible; 2.Positive for HBsAg or HBV DNA for at least 6 months (clinically diagnosed as "chronic hepatitis B"), receiving stable nucleoside/nucleotide analogues (NAs) treatment for >=3 months before screening, and able to provide test records of HBV DNA suppression; 3.Positive for HDV antibody (IgG/IgM) and having at least two quantifiable HDV RNA results with an interval of more than 3 months, and HDV RNA should be quantifiable at the time of enrollment; 4.Alanine aminotransferase (ALT) level between 1×upper limit of normal (ULN) and 10×ULN (exclusive of 1×ULN); 5.No childbearing plans within two years; females are not pregnant or lactating; subjects agree to use effective contraceptive measures throughout the entire treatment period and within 3 months after the last dose; 6.Have not participated as a subject in other clinical trials within 3 months; 7.Have good compliance with the study protocol; 8.Subjects understand and agree to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Child-Pugh class C liver function or a score >= 10 points 2.Subjects with any of the following conditions: 1)History of severe decompensated liver disease, including moderate to severe ascites (grade 2, 3), hepatic encephalopathy, gastrointestinal variceal bleeding, hepatorenal syndrome, etc., with an expected survival time of less than 2 years; 2)History of severe heart disease (including unstable or uncontrolled heart disease within 6 months or NYHA cardiac function class III-IV); 3)Uncontrolled epilepsy, severe mental illness or history of severe mental illness; 4)History of organ transplantation; 5)Uncontrolled diabetes mellitus or hypertension; 6)Subjects with autoimmune diseases, immune-related extrahepatic manifestations (vasculitis, purpura, polyarteritis nodosa, peripheral neuropathy, and glomerulonephritis), thyroid disease, malignant tumors, or receiving immunosuppressive therapy; 7)Subjects with underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, or other severe diseases; 8)History of alcoholism or drug abuse. 3.Total bilirubin > 51 µmol/L, or albumin 6 seconds 4.Creatinine clearance rate < 60 mL/min; 5.Subjects co-infected with hepatitis A, C, or E virus, or HIV; 6.Subjects who have used interferon within 3 months before screening; 7.Females with a positive pregnancy test; 8.Abnormal blood routine test results: white blood cell count (WBC) < 3×10^9/L, neutrophil count < 1.5×10^9/L, platelet count < 60×10^9/L; 9.Subjects who are taking drugs prohibited in this trial and cannot discontinue them; 10.Subjects who have used L47 or Myrcludex B within 3 months before screening; 11.Subjects receiving standardized NAs treatment with a course of less than 12 weeks; 12.Subjects with significantly abnormal results in other laboratory or auxiliary examinations, making them unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HDV RNA;Alanine aminotransferase returned to normal; | — |
Countries
China
Contacts
Public ContactNiu Junqi; Gao Yanhang
Jilin University First Hospital
Outcome results
None listed