Double-blinded, Placebo-controlled, Munticenter, Phase IIa Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D

L47-HD-IIa

A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D

2023-10-07

2024-01-30

2024-02-01

Completed

Early phase I

23

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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2024-04-24