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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 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.
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 as below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
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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 |
|---|---|---|---|---|---|---|
| Renmin Hosptial of Wuhan University | Wuhan | Hubei | China | |||
| The Second Xiangya Hospital of Central South University |
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209 participants entered the second stage of the study , and comprise the Safety Analysis Set and the Full Analysis Set
Participants completed the first stage(0-76weeks),enrolled at 9 sites in the China. The first participant was screened on 19 November 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | εPA-44 900μg | Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 εPA-44: Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 |
| FG001 | Follow-up Group | Do not give any intervention, follow-up observation only |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | Follow-up Group-placebo | These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only |
| BG001 | Follow-up Group-εPA-44 600μg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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) | Intent-to-treat population | Posted | Number | percentage of participants | Endpoint (LOCF), up to 144 weeks |
|
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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 | Follow-up Group | Do not give any intervention, follow-up observation only All safety analyzes were analyzed in a safe population, and since 1 subjects had no safety data, they were excluded from the safety population |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Proteinuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | 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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| No Intervention |
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only |
|
| 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 |
| Change From Baseline by Visit for Serum HBV DNA | week95,108,120,144 |
| 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 |
| 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 |
| Changsha |
| Hunan |
| China |
| Xiangya Hospital Central South University | Changsha | Hunan | China |
| 81th Hospital of PLA | Nanjing | Jiangsu | China |
| TangDu Hospital | XiAn | Shanxi | 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 |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Subjects moved to other city |
|
These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
| BG002 | 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 |
| BG003 | εPA-44 900μg Group-placebo | These subjects from the placebo 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 |
| BG004 | 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 |
| BG005 | 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 |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | 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 |
| OG003 | εPA-44 900μg Group-placebo | 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 |
| OG004 | 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 |
| OG005 | 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 |
|
|
| Secondary | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Intention to treat population | Posted | Number | percentage of paricipant | week95,108,120,144 |
|
|
|
| Secondary | The Proportion of Patients With Both Negative HBeAg and HBeAb. | intention to treat population | Posted | Number | percentage of paricipants | week95,108,120,144 |
|
|
|
| Secondary | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | intention to treat population | Posted | Number | percentage of participants | week95,108,120,144 |
|
|
|
| Secondary | The Proportion of Patients With Both Negative HBsAg and HBsAb. | intent-to-treat population | Posted | Number | percentage of participants | week95,108,120,144 |
|
|
|
| Secondary | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | intention to treat population | Posted | Number | percentage of participants | week95,108,120,144 |
|
|
|
| Secondary | Change From Baseline by Visit for Serum HBV DNA | intention to treat population | Posted | Mean | Standard Deviation | log_10 IU/mL | 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; | intent to treat population | Posted | Number | percentage of participants | 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 | intend to treat population | Posted | Mean | Standard Deviation | IU/ML | week95,108,120,144 |
|
|
|
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | εPA-44 900μg Group | Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 All safety analyzes were analyzed in a safe population, and since 5 subjects had no safety data, they were excluded from the safety population | 5 | 178 | 43 | 178 |
| Chronic nephritis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Severe chronic hepatitis B | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Acute exacerbation of Chronic hepatitis B | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Injection site swelling | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection site erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| weakness | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| fever | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| ALT increased | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| AST increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Leukocytes in urine positive | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Elevated transaminase | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| insomnia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Mouth ulcers | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gum pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA 15.0 | 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 |
| Week 108 |
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| Week 120 |
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| Week 144 |
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| Week 108 |
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| Week 120 |
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| Week 144 |
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| Week 108 |
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| Week 120 |
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| Week 144 |
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| Week 108 |
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| Week 120 |
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| Week 144 |
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| Week 108 |
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| Week 120 |
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| Week 144 |
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| Week 95 decreases from baseline |
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| week 108 decreases from baseline |
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| week 120 decreases from baseline |
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| week 144 decreases from baseline |
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| Week 108 |
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| Week 120 |
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| Week 144 |
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| Week 95 decreases from baseline |
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| week 108 decreases from baseline |
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| week 120 decreases from baseline |
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| week 144 decreases from baseline |
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