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A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients

Primary Purpose

Chronic Hepatitis B

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hepalatide
Placebo of Hepalatide
Tenofovir Alafenamide Tablets
Pegylated Interferon alfa 2a
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 B focused on measuring hepalatide, Hepatitis B,finite treatment,

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. HBsAg or/and HBV DNA Positive for at least 6 months

    2. HBeAg negative

    3. Received NAs stabilization therapy for at least 2 years

    4. ALT≤ 2×ULN

    5. HBV DNA< LLQD(lower limit of quantitative detection) in Screening

    6. Serum total bilirubin<2×ULN

    7. no childbirth plan within 2 years and agree to take effective contraceptive measures throughout the treatment period and within 3 months after the last dose, and that the woman is not pregnant or breastfeeding.

    8. have not participant in another clinical trial within 3 months before screening

    9. Subjects have good compliance with the protocol

    10. Subjects understood and agreed to sign the informed consent form.

Exclusion Criteria:

  • 1. Contraindications of Peginterferon such as depressive disorder, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction, etc

    2. Subjects with cirrhosis, e.g., definite cirrhosis on imaging such as abdominal ultrasound and CT; liver biopsy with Metavir fibrosis score = 4; clinical diagnosis of cirrhosis by the investigator.

    3. Decompensated liver disease

    4. Child-Pugh score of B-C or over 6 points.

    5. Subjects with any of the following circumstances

  • History of decompensated liver disease
  • History of serious heart disease (including unstable or uncontrolled heart disease within 6 months)
  • Uncontrolled seizures, severe psychiatric disorders, or a history of psychiatric disorders
  • with history of organ transplantation
  • with poorly controlled diabetes and hypertension
  • with autoimmune diseases, immune-related extrahepatic manifestations, thyroid disease, malignant tumors, or in immunosuppressive therapy
  • underlying diseases such as malignant tumor, severe infection, heart failure and chronic obstructive pulmonary disease and other serious diseases.
  • with history of alcohol or drug abuse

    6. Creatinine clearance <60 mL/min.

    7. HAV, HCV, HDV, HEV or HIV co-infection

    8. Subjects who must be treated with Nucleosides (acids) other than TAF during treatment period

    9. Subjects who used interferon in the 6 months prior to the screening period

    10. Positive for anti-HBV Pre-S1 antibody.

    11. Hemocytopenia: White blood cells < 3 × 10^9 / L, neutrophil < 1.5 × 10^9 / L, platelet < 60 × 10^9 / L,

    12. Female subjects pregnancy test positive

    13. known to be allergic to the investigational drug or the underlying treatment drug

    14. Other laboratories or auxiliary examinations are obviously abnormal

Sites / Locations

  • Shanghai Tong Ren HospitalRecruiting
  • Shanghai East Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hepalatide + TAF + PEG-IFN

Placebo+ TAF + PEG-IFN

Arm Description

Patients will receive 4.2mg Hepalatide +25mg Tenofovir alafenamide+ 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.

Patients will receive Placebo +25mg Tenofovir alafenamide + 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.

Outcomes

Primary Outcome Measures

Proportion of subjects with sustained viral response at 48 weeks off treatment
HBV DNA<20 IU/ml
Proportion of subjects with negative conversion of HBsAg
Proportion of subjects with negative conversion of HBsAg treatment at 48 weeks off treatment

Secondary Outcome Measures

Number of subjects with retreatment with NAs
Number of subjects with retreatment with NAs at 48 weeks off treatment
Number of subjects with virological relapse(VR) at 48 weeks off treatment
VR: reappearance of HBV DNA > 2000 IU/ml from undetectable status
Number of subjects with clinical relapse(CR) at 48 weeks off treatment
CR: the presence of VR with the elevation of alanine transaminase (ALT) more than two times upper limit of normal (ULN)
HBsAg is down from baseline at 48 weeks off treatment
HBsAg is down from baseline log10
Number of subjects with Serological conversion of HBsAg
Number of subjects with Serological conversion of HBsAg at 48 weeks off treatment
Change in liver stiffness at 24 weeks off treatment
The findings of Liver stiffness measurement(LSM) of Fibroscan/FibroTouch at week 48 off treatment compared to baseline

Full Information

First Posted
February 3, 2022
Last Updated
December 11, 2022
Sponsor
Shanghai HEP Pharmaceutical Co., Ltd.
Collaborators
Shanghai Tong Ren Hospital, Shanghai East Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05244057
Brief Title
A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients
Official Title
A Phase II of Randomized, Double-blind, Placebo-controlled, Multi-center Study of Hepalatide for Injection Combined With Pegylated Interferon and TAF as Finite Treatment in Chronic Hepatitis B Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai HEP Pharmaceutical Co., Ltd.
Collaborators
Shanghai Tong Ren Hospital, Shanghai East Hospital

4. Oversight

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

5. Study Description

Brief Summary
The study is designed to assess efficacy of a finitie treatment in Chronic Hepatitis B patients who had stable treatment of NAs for ≧ 2 years, which is compared hepalatide in combination with Pegylated Interferon + TAF with Pegylated Interferon +TAF. Subjects will be randomly assigned to the hepalatide or placebo groups , 15 subjects in each group . Subjects will receive hepalatide+Pegylated Interferon +TAF treatment for 48 weeks or placebo +PegylatedInterferon +TAF treatment for 48 weeks , Then, stopping all treatments and followed with further 24 weeks follow-up.
Detailed Description
Hepalatide is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection. The aim of this study is to assess efficacy of a finitie treantment , that combination regimen of hepalatide+half dose Pegylated interferon + TAF , as measured by the primary efficacy endpoint. This study will be conducted in 3 periods: Screening Period (4weeks), Treatment Period (48 weeks) and Follow-up (FU) Period (24 weeks). Safety assessments will include adverse events (AEs), serious AEs, clinical safety laboratory tests, electrocardiograms (ECGs), vital signs, ophthalmologic examinations and physical examinations. Total duration of individual participation will be up to 76 weeks (including screening period).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
hepalatide, Hepatitis B,finite treatment,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hepalatide + TAF + PEG-IFN
Arm Type
Experimental
Arm Description
Patients will receive 4.2mg Hepalatide +25mg Tenofovir alafenamide+ 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.
Arm Title
Placebo+ TAF + PEG-IFN
Arm Type
Placebo Comparator
Arm Description
Patients will receive Placebo +25mg Tenofovir alafenamide + 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Hepalatide
Other Intervention Name(s)
L47
Intervention Description
4.2mg, s.c., qd for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo of Hepalatide
Other Intervention Name(s)
Placebo
Intervention Description
s.c., qd for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Tenofovir Alafenamide Tablets
Other Intervention Name(s)
Vemlidy
Intervention Description
25mg, p.o., qd for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon alfa 2a
Other Intervention Name(s)
Pegasys
Intervention Description
90ug, s.c., qw for 48 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects with sustained viral response at 48 weeks off treatment
Description
HBV DNA<20 IU/ml
Time Frame
96 Weeks
Title
Proportion of subjects with negative conversion of HBsAg
Description
Proportion of subjects with negative conversion of HBsAg treatment at 48 weeks off treatment
Time Frame
96 Weeks
Secondary Outcome Measure Information:
Title
Number of subjects with retreatment with NAs
Description
Number of subjects with retreatment with NAs at 48 weeks off treatment
Time Frame
96 Weeks
Title
Number of subjects with virological relapse(VR) at 48 weeks off treatment
Description
VR: reappearance of HBV DNA > 2000 IU/ml from undetectable status
Time Frame
96 Weeks
Title
Number of subjects with clinical relapse(CR) at 48 weeks off treatment
Description
CR: the presence of VR with the elevation of alanine transaminase (ALT) more than two times upper limit of normal (ULN)
Time Frame
96 Weeks
Title
HBsAg is down from baseline at 48 weeks off treatment
Description
HBsAg is down from baseline log10
Time Frame
96 Weeks
Title
Number of subjects with Serological conversion of HBsAg
Description
Number of subjects with Serological conversion of HBsAg at 48 weeks off treatment
Time Frame
96 Weeks
Title
Change in liver stiffness at 24 weeks off treatment
Description
The findings of Liver stiffness measurement(LSM) of Fibroscan/FibroTouch at week 48 off treatment compared to baseline
Time Frame
96 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. HBsAg or/and HBV DNA Positive for at least 6 months 2. HBeAg negative 3. Received NAs stabilization therapy for at least 2 years 4. ALT≤ 2×ULN 5. HBV DNA< LLQD(lower limit of quantitative detection) in Screening 6. Serum total bilirubin<2×ULN 7. no childbirth plan within 2 years and agree to take effective contraceptive measures throughout the treatment period and within 3 months after the last dose, and that the woman is not pregnant or breastfeeding. 8. have not participant in another clinical trial within 3 months before screening 9. Subjects have good compliance with the protocol 10. Subjects understood and agreed to sign the informed consent form. Exclusion Criteria: 1. Contraindications of Peginterferon such as depressive disorder, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction, etc 2. Subjects with cirrhosis, e.g., definite cirrhosis on imaging such as abdominal ultrasound and CT; liver biopsy with Metavir fibrosis score = 4; clinical diagnosis of cirrhosis by the investigator. 3. Decompensated liver disease 4. Child-Pugh score of B-C or over 6 points. 5. Subjects with any of the following circumstances History of decompensated liver disease History of serious heart disease (including unstable or uncontrolled heart disease within 6 months) Uncontrolled seizures, severe psychiatric disorders, or a history of psychiatric disorders with history of organ transplantation with poorly controlled diabetes and hypertension with autoimmune diseases, immune-related extrahepatic manifestations, thyroid disease, malignant tumors, or in immunosuppressive therapy underlying diseases such as malignant tumor, severe infection, heart failure and chronic obstructive pulmonary disease and other serious diseases. with history of alcohol or drug abuse 6. Creatinine clearance <60 mL/min. 7. HAV, HCV, HDV, HEV or HIV co-infection 8. Subjects who must be treated with Nucleosides (acids) other than TAF during treatment period 9. Subjects who used interferon in the 6 months prior to the screening period 10. Positive for anti-HBV Pre-S1 antibody. 11. Hemocytopenia: White blood cells < 3 × 10^9 / L, neutrophil < 1.5 × 10^9 / L, platelet < 60 × 10^9 / L, 12. Female subjects pregnancy test positive 13. known to be allergic to the investigational drug or the underlying treatment drug 14. Other laboratories or auxiliary examinations are obviously abnormal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaolu Tang
Phone
86-21-68412368 ext 609
Email
tangxiaolu_hep@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hongli Liu
Phone
86-21-68412368 ext 605
Email
liuhongli_hep@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qin Zhang
Organizational Affiliation
Shanghai Tong Ren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tong Ren Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Zhang
Phone
181 2122 6778
Email
zq1980@shtrhospital.com
First Name & Middle Initial & Last Name & Degree
Qin Zhang
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihong Qu
Phone
18916510601
Email
18916510601@163.com
First Name & Middle Initial & Last Name & Degree
Lihong Qu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients

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