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| Name | Class |
|---|---|
| Third Military Medical University | OTHER |
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The purpose is to evaluate efficacy and safety of therapeutic Hepatitis B Virus(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.
First stage(0-76 weeks):
Eligible subjects are enrolled and assigned to 3 groups randomly in a 1:1:1 ratio:
The study cycle consists of screening and enrollment period (week -6-0), treatment period (week 0-28) and follow-up period (week 28-76).
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):
The definition of response is defined as below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| εPA-44 900μg | Experimental | Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28. |
|
| εPA-44 600μg+Placebo 300μg | Experimental | Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28. |
|
| Placebo 900μg | Placebo Comparator | Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| εPA-44 | Biological | subcutaneously injection of εPA-44 at week 0, 4, 8, 12, 20, 28. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HBeAg Seroconversion at Endpoint . | 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 76 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76 | HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication | serology response at week 12, 28, 32, 40, 52, 64, 76 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lai Wei, Ph.D. | Hepatitis Institute of Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The PLA Beijing Military General Hospital | Beijing | Beijing Municipality | China | |||
| The 2nd Affiliated Hosptial of Harbin Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34396571 | Derived | Wei L, Zhao T, Zhang J, Mao Q, Gong G, Sun Y, Chen Y, Wang M, Tan D, Gong Z, Li B, Niu J, Li S, Gong H, Zou L, Zhou W, Jia Z, Tang Y, Fei L, Hu Y, Shang X, Han J, Zhang B, Wu Y. Efficacy and safety of a nanoparticle therapeutic vaccine in patients with chronic hepatitis B: A randomized clinical trial. Hepatology. 2022 Jan;75(1):182-195. doi: 10.1002/hep.32109. Epub 2021 Dec 8. |
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1218 participants were screened and 360 were randomized; 360 randomized participants received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.
Participants were enrolled at 15 sites in the China. The first participant was screened on 26 March 2009. The last participant observation for the Week 76 analysis was on 09 October 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | εPA-44 900μg | Subcutaneous injection of εPA-44 900μg at week 0, 4, 8, 12, 20, 28. |
| FG001 | εPA-44 600μg | Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28. |
| FG002 | Placebo 900μg | Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
FAS
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| ID | Title | Description |
|---|---|---|
| BG000 | εPA-44 900μg | Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28. εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28. |
| BG001 | εPA-44 600μg+Placebo 300μg | Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28. εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28. Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With HBeAg Seroconversion at Endpoint . | Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF) | Intention-To-Treat Population | Posted | Number | percentage of participants | Endpoint(LOCF), up to 76 Weeks |
|
Adverse Events After Dosing(0-76week)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | εPA-44 900μg | Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28. εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute gastric perforation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local injection site reactions | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Wu | Institute of Immunology,PLA | 02368752230 | 86 | wuyuzhang@yahoo.com |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Placebo | Other | subcutaneously injection of Placebo at week 0, 4, 8, 12, 20, 28. |
|
| The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale; |
| week 12, 28, 32, 40, 52, 64, 76 |
| Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76 | week 12, 28, 32, 40, 52, 64, 76 |
| The Proportion of Patients With Both Negative HBeAg and HBeAb; | at week 12, 28, 32, 40, 52, 64, 76. |
| The Proportion of Patients With Positive Anti-HBe | at week 12, 28, 32, 40, 52, 64, 76. |
| Change From Baseline by Visit for HBeAg Titer | Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values | at week 12, 28, 32, 40, 52, 64, 76. |
| The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale; | week 12, 28, 32, 40, 52, 64, 76 |
| The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml; | week 12, 28, 32, 40, 52, 64, 76 |
| Change From Baseline by Visit for Serum HBV DNA | Measuring the change in value of each visit viewpoints HBV DNA titers decreased compared with baseline values | week 12, 28, 32, 40, 52, 64, 76 |
| Harbin |
| Heilongjiang |
| China |
| Renmin Hosptial of Wuhan University | Wuhan | Hubei | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Xiangya Hospital Central South University | Changsha | Hunan | China |
| 81th Hospital of PLA | Nanjing | Jiangsu | China |
| Jilin University First Hospital | Changchun | Jilin | China |
| TangDu Hospital | XiAn | Shanxi | China |
| The First Affiliated Hospital of Xi'An JiaoTong University | Xi’an | Shanxi | China |
| West China Hospital,SiChuan University | Chengdu | Sichuan | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
| 302 Militray Hosptial of China | Beijing | China |
| Hepatitis Institute of Peking University People's Hospital | Beijing | China |
| Southwest Hospital | Chongqing | China |
| Pregnancy |
|
| Protocol Violation |
|
| Unblinding |
|
| BG002 | Placebo 900μg | Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28. Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | Placebo 900μg | Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28. Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28. |
|
|
| Secondary | Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76 | HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication | Intent-to-treat population | Posted | Number | percentage of participants | serology response at week 12, 28, 32, 40, 52, 64, 76 |
|
|
|
| Secondary | The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale; | Intent-to-treat population | Posted | Number | percentage of participants | week 12, 28, 32, 40, 52, 64, 76 |
|
|
|
| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76 | Intent-to-treat population | Posted | Number | percentage of participants | week 12, 28, 32, 40, 52, 64, 76 |
|
|
|
| Secondary | The Proportion of Patients With Both Negative HBeAg and HBeAb; | Intent-to-treat population | Posted | Number | percentage of participants | at week 12, 28, 32, 40, 52, 64, 76. |
|
|
|
| Secondary | The Proportion of Patients With Positive Anti-HBe | Intent-to-treat population | Posted | Number | percentage of participants | at week 12, 28, 32, 40, 52, 64, 76. |
|
|
|
| Secondary | Change From Baseline by Visit for HBeAg Titer | Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values | Intent-to-treat population | Posted | Mean | Standard Deviation | IU/mL | at week 12, 28, 32, 40, 52, 64, 76. |
|
|
|
| Secondary | The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale; | Intent-to-treat population | Posted | Number | percentage of participants | week 12, 28, 32, 40, 52, 64, 76 |
|
|
|
| Secondary | The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml; | Intent-to-treat population | Posted | Number | percentage of participants | week 12, 28, 32, 40, 52, 64, 76 |
|
|
|
| Secondary | Change From Baseline by Visit for Serum HBV DNA | Measuring the change in value of each visit viewpoints HBV DNA titers decreased compared with baseline values | Intent-to-treat population | Posted | Mean | Standard Deviation | IU/mL | week 12, 28, 32, 40, 52, 64, 76 |
|
|
|
| 3 |
| 120 |
| 56 |
| 120 |
| EG001 | εPA-44 600μg+Placebo 300μg | Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28. εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28. Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28. | 2 | 120 | 66 | 120 |
| EG002 | Placebo 900μg | Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28. Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28. | 1 | 120 | 52 | 120 |
| Exacerbation of chronic hepatitis B | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Mediastinal bronchogenic cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abnormal liver function | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Right leg fibula fracture | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Acute exacerbation of hepatitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Injection site pain | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| weakness | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Loss of appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Coughing | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
|
| Female genital infections | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Upper abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Right upper quadrant pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site swelling | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
Investigators can't publish articles relevant to the study unless the sponsor permits.
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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