A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D
NCT Number: NCT06505928
Acronym: L47-HD-MN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatitis D
Interventions: DRUG: hepalatide
Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-09-01
Locations: National cancer canter of Monglia, Ulaanbaatar, 13370, Mongolia

Summary:
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.

Primary Outcome Measures: compound response, Decrease in HDV RNV by ≥ 2 log10 from baseline and ALT normalization, Week 48
Secondary Outcome Measures: HDV RNA below LLOQ, The incidence of subjects with HDV RNA lower than LLOQ., Week 48|Decrease in HDV RNA by ≥ 2 log10 from baseline or undetectable HDV RNA, The incidence of subjects with Decrease in HDV RNA by ≥ 2 log10 from baseline or undetectable HDV RNA, Week 48|Decrease in HDV RNA from baseline, HDV RNA reduction from baseline., Week 48|ALT normalization, The rate of ALT relapse in subjects., Week 48|Decrease in ALT from baseline, ALT reduction from baseline., Week 48|Changes in subjects' METAVIR system scores from baseline., The METAVIR score is a test used to determine the degree of inflammation and necrosis in the liver biopsy, as well as the extent of fibrosis. The degree of liver fibrosis is divided into five grades from F 0 to F4. The degree of inflammatory activity in liver tissue is divided into four grades from A0 to A3. Higher score means worse outcome.

When the liver tissue inflammation and necrosis score decreased by ≥2 points compared with baseline (the change of inflammatory activity A value compared with baseline was ≤ -2 points), and there was no increase in liver fibrosis score; Or the liver fibrosis score decreased by ≥1 point (fibrosis stage F value change from baseline ≤ 0 points)，it means Liver tissue response., Week 48|Change in fibrosis 4 (FIB-4) index from baseline, Fibrosis 4（FIB-4）Index is a non-invasive method for assessing liver fibrosis in patients with chronic liver disease. The FIB-4 index is \<1.45, indicating no significant liver fibrosis or only 2nd degree or lower liver fibrosis. And the FIB-4 index\>3.25 indicates that the degree of liver fibrosis is 3-4 or higher., Week 48|Change in Child-Pugh score from baseline, Child-Pugh scores is a test that determines the scope and severity of liver failure as well as the prognosis for the patient. Three categories "A, B and C " indicate the severity of liver breakdown on the Child-Pugh rating scale. The higher the scale, the more serious outcomes., Week 48|Change in Model for End-Stage Liver Disease (MELD) score from baseline, R = 9.6 \\\* ln(serum creatinine in mg/dl) + 3.8 \\\* ln(bilirubin in mg/dl) + 11.2 \\\* ln(INR) + 6.4 \\\* cause (cause: cholestasis and alcoholic cirrhosis = 0, viral and other causes of cirrhosis = 1). The higher the R value, the greater the risk, and the lower the survival rate., Week 48|The incidence rate of Liver-related endpoint events., The incidence of Liver-related endpoint events such as cirrhosis, hepatic decompensation, HCC, liver transplantation, liver-related death., Week 240