A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D

NCT06505928 | Active Not Recruiting Phase 2

• 1 other identifier: L47-HD-MN
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hepatitis D

Outcome Measures

Primary Outcomes (1)

• compound response

  Decrease in HDV RNV by ≥ 2 log10 from baseline and ALT normalization

  Week 48

Secondary Outcomes (10)

• HDV RNA below LLOQ

  Week 48

• Decrease in HDV RNA by ≥ 2 log10 from baseline or undetectable HDV RNA

  Week 48

• Decrease in HDV RNA from baseline

  Week 48

• ALT normalization

  Week 48

• Decrease in ALT from baseline

  Week 48

Study Arms (3)

Hepalatide 2.1mg

EXPERIMENTAL

hepalatide 2.1mg/d, s.c. for 48 weeks

Drug: hepalatide

Hepalatide 4.2mg

EXPERIMENTAL

hepalatide 4.2mg/d, s.c. for 48 weeks

Drug: hepalatide

delayed treatment groups

NO INTERVENTION

delayed treatment for 48 weeks

Interventions

hepalatide DRUG

hepalatide of 2.1 mg/d or 4.2mg/d s.c. treatment for 48 weeks

Also known as: L47

Hepalatide 2.1mg; Hepalatide 4.2mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female subjects aged 18-65 years (both inclusive);
• \. Subjects with positive HBsAg and/or HBV DNA for at least 6 months ("CHB");
• \. Subjects with positive serum anti-HDV antibody before or at screening or with positive HDV RNA for at least 6 months before screening ("CHD");
• \. Subjects with positive and quantifiable HDV RNA before enrollment;
• \. 1 × ULN \< ALT \< 10 × ULN;
• \. 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;
• \. 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);
• \. Subjects exhibiting good compliance to the study protocol;
• \. Subjects who understand the ICF and agree to sign it.

You may not qualify if:

• \. Subjects suffering from severe decompensated liver fibrosis or decompensated liver cirrhosis with a Child-Pugh score \> 7;
• \. Decompensated liver disease: Direct bilirubin \> 1.2 x ULN or prothrombin time \> 1.2 x ULN or serum albumin \< 35 g/L;
• \. Abnormal hematology findings: White blood cell count (WBC) \< 3 × 109/L, neutrophil count \< 1.5 × 109/L or platelet count \< 60 × 109/L;
• \. Creatinine clearance \< 60 mL/min;
• \. Subjects who have any of the following conditions:
• History of current or past decompensated liver diseases (including coagulopathy, hepatic encephalopathy, and variceal bleeding);
• Comorbidity of underlying diseases such as severe infection, heart failure and chronic obstructive pulmonary disease, and other severe diseases;
• Diabetes mellitus and hypertension not effectively controlled (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg);
• Current or previous uncontrolled epilepsy or psychiatric disorders;
• History of solid organ transplantation;
• Evidence of active or suspected malignancies or history of malignancies, or untreated premalignant lesions within the past 5 years (except for successfully treated cervical carcinoma in situ at least 1 year before screening, and successfully treated basal cell carcinoma and squamous cell carcinoma \[≤ 3 cases of resected skin cancer within 5 years before screening \]), or history of liver cancer;
• History of alcohol abuse or drug addiction at present or within 6 months prior to participation in this study; 6. Subjects co-infected with hepatitis A, C, or E virus or with uncontrolled HIV co-infection (those with positive HCV antibody but negative HCV RNA at screening are eligible for enrollment. HIV-infected patients may be enrolled if cluster of differentiation 4 (CD4) cell count is \> 500/mL and HIV RNA is below the limit of detection for at least 12 months);
• \. Presence of one or more other known primary or secondary liver diseases, such as alcoholism, autoimmune hepatitis, malignancies involving the liver, hemochromatosis, other congenital or metabolic diseases affecting the liver, congestive heart failure, or other serious cardiopulmonary diseases, excluding hepatitis B;
• \. Subjects with one or more autoimmune diseases, immune-related extrahepatic manifestations (such as vasculitis, purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis), or a history of requiring regular use of systemic corticosteroids (inhaled corticosteroids are allowed) or other immunosuppressive agents;
• \. Subjects who have used interferon within 6 months before screening;

Sponsors & Collaborators

• Shanghai HEP Pharmaceutical Co., Ltd.: lead

Study Sites (2)

National cancer canter of Monglia

Ulaanbaatar, 13370, Mongolia

Location

National Center for Communicable Diseases

Ulaanbaatar, Mongolia

Location

MeSH Terms

Conditions

Hepatitis D

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Oyunbileg Janchiv

  National Cacer Center of Monglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a three-arm, parallel-group, randomized, open-label, delayed-controlled phase IIb clinical trial.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: December 11, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

MO (2)