| Eligibility |
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;
- Severely decompensated hepatic fiborosis or decompensated cirrhosis: Definitely
diagnosed decompensated cirrhosis by imaging examinations such as a Color Doppler
ultrasound and CT of the abdomen or clinically diagnosed decompensated 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:
1. A history of decompensated liver disease (ascites, jaundice, hepatic
encephalopathy, variceal bleeding);
2. A history of serious cardiovascular disease (including unstable or uncontrolled
cardiovascular disease within 6 months);
3. Serious mental illness or a history of serious mental illness;
4. A history of organ transplantation;
5. Uncontrolled epilepsy, mental illness, or poorly controlled diabetes or
hypertension;
6. Autoimmune disease, immune-related extrahepatic manifestations (vasculitis,
purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis),
thyroid disease, malignant tumor, and receiving immunosuppressive therapy;
7. Underlying diseases such as severe infection, heart failure, chronic obstructive
pulmonary disease, and other severe diseases;
8. 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.
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