Study of Hepalatide in Chronic Hepatitis D(CHD) Patients

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis D Infection
• Intervention / Treatment: Drug: Hepalatide; Drug: Hepalatide Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Changchun, China
    • The First Hospital of Jilin University
  • Xinjiang
    • Urumqi, Xinjiang, China
      • The First Affiliated Hospital of Xinjiang Medical University
• Mongolia
  • Ulaanbaatar, Mongolia
    • the National cancer center of Mongolia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hepalatide 2.1mg; 2.1 mg/day subcutaneously (s.c.) for 4 week	Drug: Hepalatide; Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily.; Other Names: L47
Experimental: Hepalatide 4.2mg; 4.2 mg/day subcutaneously (s.c.) for 4 week	Drug: Hepalatide; Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily.; Other Names: L47
Experimental: Hepalatide 6.3mg; 6.3 mg/day subcutaneously (s.c.) for 4 week	Drug: Hepalatide; Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily.; Other Names: L47
Placebo Comparator: Placebo 2.1mg/4.2mg/6.3mg; Placebo 2.1 mg/4.2mg/6.3mg, once a day subcutaneously (s.c.) for 4 week	Drug: Hepalatide Placebo; Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatitis D Virus(HDV) RNA level	HDV RNA level at week4	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HDV RNA from baseline	Changes in HDV RNA levels at Week 4 compared to baseline	Week 4
Change in Alanine transaminase(ALT) from baseline	Changes in ALT values at Week 4 compared to baseline	Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALT level	ALT level at Week 4	Week 4
Number of Participants With ALT normalization	Number of Participants With Normal ALT at Week 4	Week 4

Collaborators and Investigators

• Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Junqi Niu, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2023
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: April 22, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: hepatitis D virus; hepalatide; chronic hepatitis D
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Hepatitis; Hepatitis A; Hepatitis D; Hepatitis D, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: L47-HD-IIa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No