study of hepalatide in chronic hepatitis d(chd) patients

Conditions: Chronic Hepatitis D Infection

Summary: a phase 2a clinical study of hepalatide for injection in subjects with chronic hepatitis d

this is a four-arm parallel-group, randomized, placebo-controlled, double-blind, multicenter phase iia clinical trial. the chd subjects who meet the eligibility criteria will be randomly assigned 1:1:1:1 to receive either the placebo or investigational drug (2.1 mg, 4.2 mg, or 6.3 mg), with 6 subjects per group . the placebo or the corresponding dose of the investigational drug will be given for 4 consecutive weeks, followed by a 4-week follow-up period. subjects will be given entecavir for the treatment of hepatitis b infection during and after the end of the trial.

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; * 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.

Keywords: chronic hepatitis d hepalatide hepatitis d virus