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Study of Hepalatide in Chronic Hepatitis D(CHD) Patients

Primary Purpose

Chronic Hepatitis D Infection

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hepalatide
Hepalatide Placebo
Sponsored by
Shanghai HEP Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis D Infection focused on measuring chronic hepatitis D, hepalatide, hepatitis D virus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; Severe liver fibrosis or cirrhosis: Definitely diagnosed liver cirrhosis by imaging examinations such as a Color Doppler ultrasound and CT of the abdomen or clinically diagnosed liver 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: A history of decompensated liver disease (ascites, jaundice, hepatic encephalopathy, variceal bleeding); A history of serious cardiovascular disease (including unstable or uncontrolled cardiovascular disease within 6 months); Serious mental illness or a history of serious mental illness; A history of organ transplantation; Uncontrolled epilepsy, mental illness, or poorly controlled diabetes or hypertension; Autoimmune disease, immune-related extrahepatic manifestations (vasculitis, purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis), thyroid disease, malignant tumor, and receiving immunosuppressive therapy; Underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, and other severe diseases; 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.

Sites / Locations

  • The first hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Hepalatide 2.1mg

Hepalatide 4.2mg

Hepalatide 6.3mg

Placebo 2.1mg/4.2mg/6.3mg

Arm Description

2.1 mg/day subcutaneously (s.c.) for 4 week

4.2 mg/day subcutaneously (s.c.) for 4 week

6.3 mg/day subcutaneously (s.c.) for 4 week

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

Outcomes

Primary Outcome Measures

Hepatitis D Virus(HDV) RNA level
HDV RNA level at week4

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2023
Last Updated
April 22, 2023
Sponsor
Shanghai HEP Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05827146
Brief Title
Study of Hepalatide in Chronic Hepatitis D(CHD) Patients
Official Title
Double-blinded, Placebo-controlled, Munticenter, Phase IIa Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai HEP Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis D Infection
Keywords
chronic hepatitis D, hepalatide, hepatitis D virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hepalatide 2.1mg
Arm Type
Experimental
Arm Description
2.1 mg/day subcutaneously (s.c.) for 4 week
Arm Title
Hepalatide 4.2mg
Arm Type
Experimental
Arm Description
4.2 mg/day subcutaneously (s.c.) for 4 week
Arm Title
Hepalatide 6.3mg
Arm Type
Experimental
Arm Description
6.3 mg/day subcutaneously (s.c.) for 4 week
Arm Title
Placebo 2.1mg/4.2mg/6.3mg
Arm Type
Placebo Comparator
Arm Description
Placebo 2.1 mg/4.2mg/6.3mg, once a day subcutaneously (s.c.) for 4 week
Intervention Type
Drug
Intervention Name(s)
Hepalatide
Other Intervention Name(s)
L47
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Hepalatide Placebo
Other Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hepatitis D Virus(HDV) RNA level
Description
HDV RNA level at week4
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change in Alanine transaminase(ALT) from baseline
Description
Changes in ALT values at Week 4 compared to baseline
Time Frame
Week 4
Title
Change in HDV RNA from baseline
Description
Changes in HDV RNA levels at Week 4 compared to baseline
Time Frame
Week 4
Other Pre-specified Outcome Measures:
Title
ALT level
Description
ALT level at Week 4
Time Frame
Week 4
Title
Number of Participants With ALT normalization
Description
Number of Participants With Normal ALT at Week 4
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; Severe liver fibrosis or cirrhosis: Definitely diagnosed liver cirrhosis by imaging examinations such as a Color Doppler ultrasound and CT of the abdomen or clinically diagnosed liver 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: A history of decompensated liver disease (ascites, jaundice, hepatic encephalopathy, variceal bleeding); A history of serious cardiovascular disease (including unstable or uncontrolled cardiovascular disease within 6 months); Serious mental illness or a history of serious mental illness; A history of organ transplantation; Uncontrolled epilepsy, mental illness, or poorly controlled diabetes or hypertension; Autoimmune disease, immune-related extrahepatic manifestations (vasculitis, purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis), thyroid disease, malignant tumor, and receiving immunosuppressive therapy; Underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, and other severe diseases; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaolu Tang
Phone
86-21-68412368 ext 609
Email
tangxiaolu@heppharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xian Gao
Phone
86-21-68412368 ext 605
Email
gaoxian@heppharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junqi Niu
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first hospital of Jilin University
City
Changchun
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junqi Niu
Phone
(86)0431-88782729
Email
junqiniu@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Hepalatide in Chronic Hepatitis D(CHD) Patients

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