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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862106
• Other study ID #: 71006.01-2
• Status: Completed
• Phase: Phase 2
• Start date: September 2010
• Est. completion date: March 2013

Study information

• Verified date: November 2016
• Source: Chongqing Jiachen Biotechnology Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• ePA-44
subcutaneously injection of ePA-44 900µg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128

Locations

Country	Name	City	State
China	302 Militray Hosptial of China	Beijing
China	Hepatitis Institute of Peking University People's Hospital	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	ChangSha	Hunan
China	Southwest Hospital	ChongQing
China	81th Hospital of PLA	NanJing	Jiangsu
China	The First Affiliated Hospital of Wenzhou Medical University	WenZhou	Zhejiang
China	Renmin Hosptial of Wuhan University	WuHan	Hubei
China	TangDu Hospital	XiAn	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Chongqing Jiachen Biotechnology Ltd.	Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

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