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Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
εPA-44
Sponsored by
Chongqing Jiachen Biotechnology Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic Hepatitis B, HBeAg positive, Therapeutic HBV Vaccine, HBV-specific Cytotoxic T Lymphocyte

Eligibility Criteria

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

Inclusion Criteria:

  1. The subjects completed the first stage study(0-76 weeks) and willing to willing to participate in the trial
  2. Uses effective contraception for subject with child-bearing potential (including females and female partners of males)
  3. Understands and signs ICF approved by EC
  4. Willing to comply with the study procedures and complete the study

Exclusion Criteria:

1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator

Sites / Locations

  • Renmin Hosptial of Wuhan University
  • The Second Xiangya Hospital of Central South University
  • Xiangya Hospital Central South University
  • 81th Hospital of PLA
  • TangDu Hospital
  • The First Affiliated Hospital of Wenzhou Medical University
  • 302 Militray Hosptial of China
  • Hepatitis Institute of Peking University People's Hospital
  • Southwest Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

No Intervention

No Intervention

No Intervention

Arm Label

εPA-44 900μg group-placebo

εPA-44 900μg group-εPA-44 600μg

εPA-44 900μg group-εPA-44 900μg

Follow-up group-placebo

Follow-up group-εPA-44 600μg

Follow-up group-εPA-44 900μg

Arm Description

These subjects from the placebo group of protocol 71006.01 InjectεPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128

These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128

These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128

These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only

These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only

These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only

Outcomes

Primary Outcome Measures

The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)

Secondary Outcome Measures

The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
The Proportion of Patients With Both Negative HBeAg and HBeAb.
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
The Proportion of Patients With Both Negative HBsAg and HBsAb.
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Change From Baseline by Visit for Serum HBV DNA
Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;
Change From Baseline by Vsit for HBeAg Titer.
Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values

Full Information

First Posted
August 6, 2016
Last Updated
August 11, 2019
Sponsor
Chongqing Jiachen Biotechnology Ltd.
Collaborators
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02862106
Brief Title
Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
Official Title
Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chongqing Jiachen Biotechnology Ltd.
Collaborators
Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.
Detailed Description
Second stage(76-144 weeks): In this follow-up stage the trial is open designed, and all the subjects completed the first stage study(0-76 weeks) Subjects with virological response but no serological response/with serological response but no virological response/neither virological nor serological response in the first stage, and be willing to continue the this follow-up study, will be treated by εPA-44 900 μg at week 80,83,86,89,92,95,98,101,104,108,112,116,120,124,128. Subjects with both virological and serological response, will be followed-up to 144 weeks with no Adefovir Dipivoxil or εPA-44 900 μg treatment. The definition of response as below: Virological response: HBV DNA<2.93×10∧3IU/ml at 76 weeks; Serological response: serological conversion of HBeAg at 76 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Chronic Hepatitis B, HBeAg positive, Therapeutic HBV Vaccine, HBV-specific Cytotoxic T Lymphocyte

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
εPA-44 900μg group-placebo
Arm Type
Experimental
Arm Description
These subjects from the placebo group of protocol 71006.01 InjectεPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Arm Title
εPA-44 900μg group-εPA-44 600μg
Arm Type
Experimental
Arm Description
These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Arm Title
εPA-44 900μg group-εPA-44 900μg
Arm Type
Experimental
Arm Description
These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Arm Title
Follow-up group-placebo
Arm Type
No Intervention
Arm Description
These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
Arm Title
Follow-up group-εPA-44 600μg
Arm Type
No Intervention
Arm Description
These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
Arm Title
Follow-up group-εPA-44 900μg
Arm Type
No Intervention
Arm Description
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
Intervention Type
Biological
Intervention Name(s)
εPA-44
Other Intervention Name(s)
Therapeutic HBV vaccine
Intervention Description
subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Primary Outcome Measure Information:
Title
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period
Description
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
Time Frame
Endpoint (LOCF), up to 144 weeks
Secondary Outcome Measure Information:
Title
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
Time Frame
week95,108,120,144
Title
The Proportion of Patients With Both Negative HBeAg and HBeAb.
Time Frame
week95,108,120,144
Title
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
Time Frame
week95,108,120,144
Title
The Proportion of Patients With Both Negative HBsAg and HBsAb.
Time Frame
week95,108,120,144
Title
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Time Frame
week95,108,120,144
Title
Change From Baseline by Visit for Serum HBV DNA
Time Frame
week95,108,120,144
Title
Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;
Time Frame
week95,108,120,144
Title
Change From Baseline by Vsit for HBeAg Titer.
Description
Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values
Time Frame
week95,108,120,144

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: The subjects completed the first stage study(0-76 weeks) and willing to willing to participate in the trial Uses effective contraception for subject with child-bearing potential (including females and female partners of males) Understands and signs ICF approved by EC Willing to comply with the study procedures and complete the study Exclusion Criteria: 1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lai Wei, Ph.D.
Organizational Affiliation
Hepatitis Institute of Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renmin Hosptial of Wuhan University
City
WuHan
State/Province
Hubei
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Xiangya Hospital Central South University
City
ChangSha
State/Province
Hunan
Country
China
Facility Name
81th Hospital of PLA
City
NanJing
State/Province
Jiangsu
Country
China
Facility Name
TangDu Hospital
City
XiAn
State/Province
Shanxi
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
WenZhou
State/Province
Zhejiang
Country
China
Facility Name
302 Militray Hosptial of China
City
Beijing
Country
China
Facility Name
Hepatitis Institute of Peking University People's Hospital
City
Beijing
Country
China
Facility Name
Southwest Hospital
City
ChongQing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B

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