Study of Hepalatide in Chronic Hepatitis D(CHD) Patients

Phase 2

Completed

• Conditions: Chronic Hepatitis D Infection
• Interventions: Drug: Hepalatide; Drug: Hepalatide Placebo

• Registration Number: NCT05827146
• Lead Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-04-22
• Study First Posted: 2023-04-24
• Study Start: 2023-10-07
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hepalatide 2.1mg	Hepalatide	2.1 mg/day subcutaneously (s.c.) for 4 week
Hepalatide 4.2mg	Hepalatide	4.2 mg/day subcutaneously (s.c.) for 4 week
Placebo 2.1mg/4.2mg/6.3mg	Hepalatide Placebo	Placebo 2.1 mg/4.2mg/6.3mg, once a day subcutaneously (s.c.) for 4 week
Hepalatide 6.3mg	Hepalatide	6.3 mg/day subcutaneously (s.c.) for 4 week

Primary Outcome Measures

Name	Time	Method
Hepatitis D Virus(HDV) RNA level	Week 4	HDV RNA level at week4

Secondary Outcome Measures

Name	Time	Method
Change in Alanine transaminase(ALT) from baseline	Week 4	Changes in ALT values at Week 4 compared to baseline
Change in HDV RNA from baseline	Week 4	Changes in HDV RNA levels at Week 4 compared to baseline

Trial Locations

Locations (3)

The first hospital of Jilin University; 🇨🇳 Changchun, China

The first affiliated hospital of Xinjiang Medical University; 🇨🇳 Urumqi, Xinjiang, China

the National cancer center of Mongolia; 🇲🇳 Ulaanbaatar, Mongolia