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OpenTrials
Completed

NCT Number: NCT02862106

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Renmin Hosptial of Wuhan University, Wuhan, Hubei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

εPA-44

Biological

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chongqing Jiachen Biotechnology Ltd.

Industry

Collaborators

  • Third Military Medical University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 10, 2016
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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