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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02862106
Recruitment Status : Completed
First Posted : August 10, 2016
Results First Posted : January 18, 2017
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Third Military Medical University
Information provided by (Responsible Party):
Chongqing Jiachen Biotechnology Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Biological: εPA-44 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
Study Start Date : September 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 [ Time Frame: week95,108,120,144 ]
  2. The Proportion of Patients With Both Negative HBeAg and HBeAb. [ Time Frame: week95,108,120,144 ]
  3. The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 [ Time Frame: week95,108,120,144 ]
  4. The Proportion of Patients With Both Negative HBsAg and HBsAb. [ Time Frame: week95,108,120,144 ]
  5. The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit [ Time Frame: week95,108,120,144 ]
  6. Change From Baseline by Visit for Serum HBV DNA [ Time Frame: week95,108,120,144 ]
  7. 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 ]
  8. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862106


Locations
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China, Hubei
Renmin Hosptial of Wuhan University
WuHan, Hubei, China
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
ChangSha, Hunan, China
China, Jiangsu
81th Hospital of PLA
NanJing, Jiangsu, China
China, Shanxi
TangDu Hospital
XiAn, Shanxi, China
China, Zhejiang
The First Affiliated Hospital of Wenzhou Medical University
WenZhou, Zhejiang, China
China
302 Militray Hosptial of China
Beijing, China
Hepatitis Institute of Peking University People's Hospital
Beijing, China
Southwest Hospital
ChongQing, China
Sponsors and Collaborators
Chongqing Jiachen Biotechnology Ltd.
Third Military Medical University
Investigators
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Principal Investigator: Lai Wei, Ph.D. Hepatitis Institute of Peking University People's Hospital
More Information
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Responsible Party: Chongqing Jiachen Biotechnology Ltd.
ClinicalTrials.gov Identifier: NCT02862106    
Other Study ID Numbers: 71006.01-2
First Posted: August 10, 2016    Key Record Dates
Results First Posted: January 18, 2017
Last Update Posted: August 20, 2019
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chongqing Jiachen Biotechnology Ltd.:
Chronic Hepatitis B
HBeAg positive
Therapeutic HBV Vaccine
HBV-specific Cytotoxic T Lymphocyte
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs