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

August 11, 2019 updated by: Chongqing Jiachen Biotechnology Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

  1. 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.
  2. 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:

  1. Virological response: HBV DNA<2.93×10∧3IU/ml at 76 weeks;
  2. Serological response: serological conversion of HBeAg at 76 weeks.

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • 302 Militray Hosptial of China
      • Beijing, China
        • Hepatitis Institute of Peking University People's Hospital
      • ChongQing, China
        • Southwest Hospital
    • Hubei
      • WuHan, Hubei, China
        • Renmin hosptial of Wuhan University
    • Hunan
      • ChangSha, Hunan, China
        • Xiangya Hospital Central South University
      • Changsha, Hunan, China
        • The second Xiangya Hospital of Central South University
    • Jiangsu
      • NanJing, Jiangsu, China
        • 81th Hospital of PLA
    • Shanxi
      • XiAn, Shanxi, China
        • Tangdu Hospital
    • Zhejiang
      • WenZhou, Zhejiang, China
        • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: εPA-44 900μg group-placebo
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
Biological: εPA-44
subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Other Names:
  • Therapeutic HBV vaccine
Experimental: εPA-44 900μg group-εPA-44 600μg
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
Biological: εPA-44
subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Other Names:
  • Therapeutic HBV vaccine
Experimental: εPA-44 900μg group-εPA-44 900μg
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
Biological: εPA-44
subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Other Names:
  • Therapeutic HBV vaccine
No Intervention: Follow-up group-placebo
These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
No Intervention: Follow-up group-εPA-44 600μg
These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
No Intervention: Follow-up group-εPA-44 900μg
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period
Time Frame: Endpoint (LOCF), up to 144 weeks
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
Endpoint (LOCF), up to 144 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
Time Frame: week95,108,120,144
week95,108,120,144
The Proportion of Patients With Both Negative HBeAg and HBeAb.
Time Frame: week95,108,120,144
week95,108,120,144
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
Time Frame: week95,108,120,144
week95,108,120,144
The Proportion of Patients With Both Negative HBsAg and HBsAb.
Time Frame: week95,108,120,144
week95,108,120,144
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Time Frame: week95,108,120,144
week95,108,120,144
Change From Baseline by Visit for Serum HBV DNA
Time Frame: week95,108,120,144
week95,108,120,144
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
week95,108,120,144
Change From Baseline by Vsit for HBeAg Titer.
Time Frame: week95,108,120,144
Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values
week95,108,120,144

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Jiachen Biotechnology Ltd.

Collaborators

Third Military Medical University

Investigators

  • Principal Investigator: Lai Wei, Ph.D., Hepatitis Institute of Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 6, 2016

First Submitted That Met QC Criteria

August 6, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 11, 2019

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71006.01-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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