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

NCT02862106 | Completed Phase 2 Results DMC

• 1 other identifier: 71006.01-2
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 9

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.

Conditions

Chronic Hepatitis B

Keywords

Chronic Hepatitis B; HBeAg positive; Therapeutic HBV Vaccine; HBV-specific Cytotoxic T Lymphocyte

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144

  week95,108,120,144

• The Proportion of Patients With Both Negative HBeAg and HBeAb.

  week95,108,120,144

• The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144

  week95,108,120,144

• The Proportion of Patients With Both Negative HBsAg and HBsAb.

  week95,108,120,144

• The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit

  week95,108,120,144

Study Arms (6)

εPA-44 900μg group-placebo

EXPERIMENTAL

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

εPA-44 900μg group-εPA-44 600μg

EXPERIMENTAL

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

εPA-44 900μg group-εPA-44 900μg

EXPERIMENTAL

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

Follow-up group-placebo

NO INTERVENTION

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

Follow-up group-εPA-44 600μg

NO INTERVENTION

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

Follow-up group-εPA-44 900μg

NO INTERVENTION

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

Interventions

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

Also known as: Therapeutic HBV vaccine

εPA-44 900μg group-placebo; εPA-44 900μg group-εPA-44 600μg; εPA-44 900μg group-εPA-44 900μg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chongqing Jiachen Biotechnology Ltd.: lead
• Third Military Medical University: collaborator

Study Sites (9)

Renmin Hosptial of Wuhan University

Wuhan, Hubei, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

81th Hospital of PLA

Nanjing, Jiangsu, China

Location

TangDu Hospital

XiAn, Shanxi, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

302 Militray Hosptial of China

Beijing, China

Location

Hepatitis Institute of Peking University People's Hospital

Beijing, China

Location

Southwest Hospital

Chongqing, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr.Wu
• Organization: Institute of Immunology，PLA

wuyuzhang@yahoo.com

02368752230

Study Officials

• Lai Wei, Ph.D.

  Hepatitis Institute of Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2016
• First Posted: August 10, 2016
• Study Start: September 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 20, 2019
• Results First Posted: January 18, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)