A Parallel-group, Randomized, Open-label Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D.
The goal of this clinical trial is to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D. Patients with compensated CHD who satisfy the eligibility criteria are stratified by the presence or absence of liver cirrhosis and randomized into three groups at a 1:1:1 ratio. The subjects will receive continuous L47 (2.1 mg/d and 4.2 mg/d, s.c.) treatment for 48 weeks (groups A and B), or delayed treatment for 48 weeks (group C). Primary endpoint evaluation will be performed after the subjects complete the 48-week treatment.
• 1\. Male or female subjects aged 18-65 years (both inclusive);
• 2\. Subjects with positive HBsAg and/or HBV DNA for at least 6 months (CHB);
• 3\. Subjects with positive serum anti-HDV antibody before or at screening or with positive HDV RNA for at least 6 months before screening (CHD);
• 4\. Subjects with positive and quantifiable HDV RNA before enrollment;
• 5\. 1 × ULN \< ALT \< 10 × ULN;
• 6\. Subjects who should be treated with nucleoside/nucleotide reverse transcriptase inhibitors at enrollment or after enrollment according to the guidelines for the treatment of hepatitis D (compensated cirrhosis with detectable HBV DNA, or HBV DNA \> 2000 IU/mL in patients without cirrhosis) and consent to the use of entecavir for the treatment of chronic hepatitis B;
• 7\. Subjects who do not plan a pregnancy within 3 years (women who are not pregnant or lactating, and males who agree to take effective contraceptive measures throughout the treatment period and for 3 months after the last dose);
• 8\. Subjects exhibiting good compliance to the study protocol;
• 9\. Subjects who understand the ICF and agree to sign it.