Chronic Hepatitis B
Conditions
Keywords
Chronic Hepatitis B, HBeAg positive, Therapeutic HBV Vaccine, HBV-specific Cytotoxic T Lymphocyte
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.
Detailed 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.
Interventions
BIOLOGICALεPA-44
subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
Sponsors
Third Military Medical University
Chongqing Jiachen Biotechnology Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline by Vsit for HBeAg Titer. | week95,108,120,144 | Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values |
| 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 | — |
| 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 | — |
| 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 | — |
| The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | week95,108,120,144 | — |
Countries
China
Participant flow
Recruitment details
Participants completed the first stage(0-76weeks),enrolled at 9 sites in the China. The first participant was screened on 19 November 2011.
Pre-assignment details
209 participants entered the second stage of the study , and comprise the Safety Analysis Set and the Full Analysis Set
Participants by arm
| Arm | Count |
|---|---|
| Follow-up Group-placebo These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only | 3 |
| Follow-up Group-εPA-44 600μg These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only | 12 |
| 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 | 10 |
| 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 | 64 |
| 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 | 56 |
| 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 | 58 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Lost to Follow-up | 15 | 5 |
| Overall Study | Protocol Violation | 16 | 1 |
| Overall Study | Subjects moved to other city | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Follow-up Group-εPA-44 600μg | Follow-up Group-εPA-44 900μg | εPA-44 900μg Group-placebo | Follow-up Group-placebo | εPA-44 900μg Group-εPA-44 600μg | εPA-44 900μg Group-εPA-44 900μg | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 10 Participants | 64 Participants | 3 Participants | 56 Participants | 58 Participants | 203 Participants |
| Age, Continuous | 25.2 years STANDARD_DEVIATION 4.39 | 25.8 years STANDARD_DEVIATION 8.02 | 30.4 years STANDARD_DEVIATION 7.56 | 32.7 years STANDARD_DEVIATION 6.03 | 29.6 years STANDARD_DEVIATION 9.14 | 29.4 years STANDARD_DEVIATION 7.61 | 29.4 years STANDARD_DEVIATION 7.96 |
| BMI | 21.23 kg/m^2 STANDARD_DEVIATION 2.181 | 21.42 kg/m^2 STANDARD_DEVIATION 2.601 | 21.95 kg/m^2 STANDARD_DEVIATION 2.615 | 22.69 kg/m^2 STANDARD_DEVIATION 4.043 | 21.76 kg/m^2 STANDARD_DEVIATION 3.273 | 22.12 kg/m^2 STANDARD_DEVIATION 2.792 | 21.89 kg/m^2 STANDARD_DEVIATION 2.835 |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 16 Participants | 1 Participants | 8 Participants | 16 Participants | 50 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 48 Participants | 2 Participants | 48 Participants | 42 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 25 | 43 / 178 |
| serious Total, serious adverse events | 0 / 25 | 5 / 178 |
Outcome results
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)
Time frame: Endpoint (LOCF), up to 144 weeks
Population: Intent-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Follow-up Group-placebo | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period | 66.7 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period | 100 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period | 100 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period | 38.7 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period | 40 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period | 34.5 percentage of participants |
Secondary
Change From Baseline by Visit for Serum HBV DNA
Time frame: week95,108,120,144
Population: intention to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Follow-up Group-placebo | Change From Baseline by Visit for Serum HBV DNA | week 120 decreases from baseline | 5.5 log_10 IU/mL | Standard Deviation 0.97 |
| Follow-up Group-placebo | Change From Baseline by Visit for Serum HBV DNA | Week 95 decreases from baseline | 6.0 log_10 IU/mL | Standard Deviation 0.67 |
| Follow-up Group-placebo | Change From Baseline by Visit for Serum HBV DNA | Baseline values of log | 8.1 log_10 IU/mL | Standard Deviation 0.64 |
| Follow-up Group-placebo | Change From Baseline by Visit for Serum HBV DNA | week 144 decreases from baseline | 5.6 log_10 IU/mL | Standard Deviation 0.34 |
| Follow-up Group-placebo | Change From Baseline by Visit for Serum HBV DNA | week 108 decreases from baseline | 6.3 log_10 IU/mL | Standard Deviation 0.14 |
| Follow-up Group-εPA-44 600μg | Change From Baseline by Visit for Serum HBV DNA | Week 95 decreases from baseline | 5.1 log_10 IU/mL | Standard Deviation 1.23 |
| Follow-up Group-εPA-44 600μg | Change From Baseline by Visit for Serum HBV DNA | week 120 decreases from baseline | 5.2 log_10 IU/mL | Standard Deviation 0.99 |
| Follow-up Group-εPA-44 600μg | Change From Baseline by Visit for Serum HBV DNA | Baseline values of log | 7.6 log_10 IU/mL | Standard Deviation 0.97 |
| Follow-up Group-εPA-44 600μg | Change From Baseline by Visit for Serum HBV DNA | week 144 decreases from baseline | 5.1 log_10 IU/mL | Standard Deviation 1.09 |
| Follow-up Group-εPA-44 600μg | Change From Baseline by Visit for Serum HBV DNA | week 108 decreases from baseline | 5.2 log_10 IU/mL | Standard Deviation 1.24 |
| Follow-up Group-εPA-44 900μg | Change From Baseline by Visit for Serum HBV DNA | Week 95 decreases from baseline | 5.6 log_10 IU/mL | Standard Deviation 0.92 |
| Follow-up Group-εPA-44 900μg | Change From Baseline by Visit for Serum HBV DNA | week 120 decreases from baseline | 5.9 log_10 IU/mL | Standard Deviation 0.83 |
| Follow-up Group-εPA-44 900μg | Change From Baseline by Visit for Serum HBV DNA | week 144 decreases from baseline | 5.6 log_10 IU/mL | Standard Deviation 1.21 |
| Follow-up Group-εPA-44 900μg | Change From Baseline by Visit for Serum HBV DNA | week 108 decreases from baseline | 5.4 log_10 IU/mL | Standard Deviation 0.71 |
| Follow-up Group-εPA-44 900μg | Change From Baseline by Visit for Serum HBV DNA | Baseline values of log | 7.5 log_10 IU/mL | Standard Deviation 1.1 |
| εPA-44 900μg Group-placebo | Change From Baseline by Visit for Serum HBV DNA | week 108 decreases from baseline | 3.0 log_10 IU/mL | Standard Deviation 2.1 |
| εPA-44 900μg Group-placebo | Change From Baseline by Visit for Serum HBV DNA | Baseline values of log | 7.8 log_10 IU/mL | Standard Deviation 0.88 |
| εPA-44 900μg Group-placebo | Change From Baseline by Visit for Serum HBV DNA | Week 95 decreases from baseline | 2.8 log_10 IU/mL | Standard Deviation 1.83 |
| εPA-44 900μg Group-placebo | Change From Baseline by Visit for Serum HBV DNA | week 120 decreases from baseline | 3.0 log_10 IU/mL | Standard Deviation 2.19 |
| εPA-44 900μg Group-placebo | Change From Baseline by Visit for Serum HBV DNA | week 144 decreases from baseline | 3.2 log_10 IU/mL | Standard Deviation 2.27 |
| εPA-44 900μg Group-εPA-44 600μg | Change From Baseline by Visit for Serum HBV DNA | week 120 decreases from baseline | 3.3 log_10 IU/mL | Standard Deviation 1.94 |
| εPA-44 900μg Group-εPA-44 600μg | Change From Baseline by Visit for Serum HBV DNA | Baseline values of log | 8.1 log_10 IU/mL | Standard Deviation 0.9 |
| εPA-44 900μg Group-εPA-44 600μg | Change From Baseline by Visit for Serum HBV DNA | week 144 decreases from baseline | 4.1 log_10 IU/mL | Standard Deviation 1.77 |
| εPA-44 900μg Group-εPA-44 600μg | Change From Baseline by Visit for Serum HBV DNA | Week 95 decreases from baseline | 2.7 log_10 IU/mL | Standard Deviation 2.18 |
| εPA-44 900μg Group-εPA-44 600μg | Change From Baseline by Visit for Serum HBV DNA | week 108 decreases from baseline | 3.1 log_10 IU/mL | Standard Deviation 2.17 |
| εPA-44 900μg Group-εPA-44 900μg | Change From Baseline by Visit for Serum HBV DNA | Baseline values of log | 8.0 log_10 IU/mL | Standard Deviation 0.99 |
| εPA-44 900μg Group-εPA-44 900μg | Change From Baseline by Visit for Serum HBV DNA | week 120 decreases from baseline | 2.8 log_10 IU/mL | Standard Deviation 2.66 |
| εPA-44 900μg Group-εPA-44 900μg | Change From Baseline by Visit for Serum HBV DNA | Week 95 decreases from baseline | 2.9 log_10 IU/mL | Standard Deviation 2.34 |
| εPA-44 900μg Group-εPA-44 900μg | Change From Baseline by Visit for Serum HBV DNA | week 144 decreases from baseline | 3.3 log_10 IU/mL | Standard Deviation 2.69 |
| εPA-44 900μg Group-εPA-44 900μg | Change From Baseline by Visit for Serum HBV DNA | week 108 decreases from baseline | 3.2 log_10 IU/mL | Standard Deviation 2.4 |
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
Time frame: week95,108,120,144
Population: intend to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Follow-up Group-placebo | Change From Baseline by Vsit for HBeAg Titer. | week 120 decreases from baseline | -446.3 IU/ML | Standard Deviation 237.64 |
| Follow-up Group-placebo | Change From Baseline by Vsit for HBeAg Titer. | Week 95 decreases from baseline | -1276.3 IU/ML | Standard Deviation 1447.33 |
| Follow-up Group-placebo | Change From Baseline by Vsit for HBeAg Titer. | week 108 decreases from baseline | -446.3 IU/ML | Standard Deviation 237.59 |
| Follow-up Group-placebo | Change From Baseline by Vsit for HBeAg Titer. | baseline of HBeAg titers | 1276.5 IU/ML | Standard Deviation 1447.33 |
| Follow-up Group-placebo | Change From Baseline by Vsit for HBeAg Titer. | week 144 decreases from baseline | -446.3 IU/ML | Standard Deviation 237.59 |
| Follow-up Group-εPA-44 600μg | Change From Baseline by Vsit for HBeAg Titer. | baseline of HBeAg titers | 758.5 IU/ML | Standard Deviation 1287.52 |
| Follow-up Group-εPA-44 600μg | Change From Baseline by Vsit for HBeAg Titer. | week 120 decreases from baseline | -979.9 IU/ML | Standard Deviation 1463.54 |
| Follow-up Group-εPA-44 600μg | Change From Baseline by Vsit for HBeAg Titer. | week 144 decreases from baseline | -923.9 IU/ML | Standard Deviation 1379.3 |
| Follow-up Group-εPA-44 600μg | Change From Baseline by Vsit for HBeAg Titer. | Week 95 decreases from baseline | -758.3 IU/ML | Standard Deviation 1287.52 |
| Follow-up Group-εPA-44 600μg | Change From Baseline by Vsit for HBeAg Titer. | week 108 decreases from baseline | -758.3 IU/ML | Standard Deviation 1287.52 |
| Follow-up Group-εPA-44 900μg | Change From Baseline by Vsit for HBeAg Titer. | week 144 decreases from baseline | -285.7 IU/ML | Standard Deviation 411.9 |
| Follow-up Group-εPA-44 900μg | Change From Baseline by Vsit for HBeAg Titer. | week 120 decreases from baseline | -314.4 IU/ML | Standard Deviation 576.36 |
| Follow-up Group-εPA-44 900μg | Change From Baseline by Vsit for HBeAg Titer. | baseline of HBeAg titers | 285.9 IU/ML | Standard Deviation 411.9 |
| Follow-up Group-εPA-44 900μg | Change From Baseline by Vsit for HBeAg Titer. | week 108 decreases from baseline | -38.9 IU/ML | Standard Deviation 49.73 |
| Follow-up Group-εPA-44 900μg | Change From Baseline by Vsit for HBeAg Titer. | Week 95 decreases from baseline | -285.7 IU/ML | Standard Deviation 411.9 |
| εPA-44 900μg Group-placebo | Change From Baseline by Vsit for HBeAg Titer. | baseline of HBeAg titers | 681.9 IU/ML | Standard Deviation 658.52 |
| εPA-44 900μg Group-placebo | Change From Baseline by Vsit for HBeAg Titer. | Week 95 decreases from baseline | -435.8 IU/ML | Standard Deviation 685.25 |
| εPA-44 900μg Group-placebo | Change From Baseline by Vsit for HBeAg Titer. | week 108 decreases from baseline | -476.8 IU/ML | Standard Deviation 728.21 |
| εPA-44 900μg Group-placebo | Change From Baseline by Vsit for HBeAg Titer. | week 120 decreases from baseline | -500.7 IU/ML | Standard Deviation 654.06 |
| εPA-44 900μg Group-placebo | Change From Baseline by Vsit for HBeAg Titer. | week 144 decreases from baseline | -546.3 IU/ML | Standard Deviation 629.66 |
| εPA-44 900μg Group-εPA-44 600μg | Change From Baseline by Vsit for HBeAg Titer. | week 120 decreases from baseline | -769.4 IU/ML | Standard Deviation 1017.49 |
| εPA-44 900μg Group-εPA-44 600μg | Change From Baseline by Vsit for HBeAg Titer. | baseline of HBeAg titers | 958.3 IU/ML | Standard Deviation 929.45 |
| εPA-44 900μg Group-εPA-44 600μg | Change From Baseline by Vsit for HBeAg Titer. | week 144 decreases from baseline | -788.4 IU/ML | Standard Deviation 887.7 |
| εPA-44 900μg Group-εPA-44 600μg | Change From Baseline by Vsit for HBeAg Titer. | Week 95 decreases from baseline | -617.1 IU/ML | Standard Deviation 913.09 |
| εPA-44 900μg Group-εPA-44 600μg | Change From Baseline by Vsit for HBeAg Titer. | week 108 decreases from baseline | -807.0 IU/ML | Standard Deviation 1011.18 |
| εPA-44 900μg Group-εPA-44 900μg | Change From Baseline by Vsit for HBeAg Titer. | baseline of HBeAg titers | 880.9 IU/ML | Standard Deviation 1368.65 |
| εPA-44 900μg Group-εPA-44 900μg | Change From Baseline by Vsit for HBeAg Titer. | week 120 decreases from baseline | -486.3 IU/ML | Standard Deviation 927.24 |
| εPA-44 900μg Group-εPA-44 900μg | Change From Baseline by Vsit for HBeAg Titer. | Week 95 decreases from baseline | -550.7 IU/ML | Standard Deviation 1834.16 |
| εPA-44 900μg Group-εPA-44 900μg | Change From Baseline by Vsit for HBeAg Titer. | week 144 decreases from baseline | -691.5 IU/ML | Standard Deviation 1708.44 |
| εPA-44 900μg Group-εPA-44 900μg | Change From Baseline by Vsit for HBeAg Titer. | week 108 decreases from baseline | -602.9 IU/ML | Standard Deviation 1755.5 |
Secondary
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
Population: intent to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Follow-up Group-placebo | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 95 | 100 percentage of participants |
| Follow-up Group-placebo | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 108 | 66.7 percentage of participants |
| Follow-up Group-placebo | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 120 | 66.7 percentage of participants |
| Follow-up Group-placebo | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 144 | 66.7 percentage of participants |
| Follow-up Group-εPA-44 600μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 120 | 72.7 percentage of participants |
| Follow-up Group-εPA-44 600μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 108 | 100 percentage of participants |
| Follow-up Group-εPA-44 600μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 95 | 100 percentage of participants |
| Follow-up Group-εPA-44 600μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 144 | 81.8 percentage of participants |
| Follow-up Group-εPA-44 900μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 144 | 100 percentage of participants |
| Follow-up Group-εPA-44 900μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 120 | 44.4 percentage of participants |
| Follow-up Group-εPA-44 900μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 108 | 55.6 percentage of participants |
| Follow-up Group-εPA-44 900μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 95 | 100 percentage of participants |
| εPA-44 900μg Group-placebo | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 95 | 59.7 percentage of participants |
| εPA-44 900μg Group-placebo | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 144 | 61.2 percentage of participants |
| εPA-44 900μg Group-placebo | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 108 | 61.3 percentage of participants |
| εPA-44 900μg Group-placebo | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 120 | 54.8 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 120 | 58.2 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 144 | 58.2 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 108 | 60.0 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 95 | 52.7 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 108 | 60.3 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 120 | 43.1 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 144 | 55.2 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; | Week 95 | 60.3 percentage of participants |
Secondary
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
Time frame: week95,108,120,144
Population: Intention to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Follow-up Group-placebo | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 95 | 66.7 percentage of paricipant |
| Follow-up Group-placebo | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 108 | 33.3 percentage of paricipant |
| Follow-up Group-placebo | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 120 | 33.3 percentage of paricipant |
| Follow-up Group-placebo | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 144 | 33.3 percentage of paricipant |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 120 | 72.7 percentage of paricipant |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 108 | 100 percentage of paricipant |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 95 | 100 percentage of paricipant |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 144 | 81.8 percentage of paricipant |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 144 | 100 percentage of paricipant |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 120 | 44.4 percentage of paricipant |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 108 | 55.6 percentage of paricipant |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 95 | 100 percentage of paricipant |
| εPA-44 900μg Group-placebo | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 95 | 25.8 percentage of paricipant |
| εPA-44 900μg Group-placebo | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 144 | 37.1 percentage of paricipant |
| εPA-44 900μg Group-placebo | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 108 | 32.3 percentage of paricipant |
| εPA-44 900μg Group-placebo | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 120 | 29.0 percentage of paricipant |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 120 | 30.9 percentage of paricipant |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 144 | 32.7 percentage of paricipant |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 108 | 32.7 percentage of paricipant |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 95 | 21.8 percentage of paricipant |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 108 | 34.5 percentage of paricipant |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 120 | 25.9 percentage of paricipant |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 144 | 27.6 percentage of paricipant |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 | Week 95 | 34.5 percentage of paricipant |
Secondary
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
Time frame: week95,108,120,144
Population: intention to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Follow-up Group-placebo | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 95 | 0 percentage of participants |
| Follow-up Group-placebo | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 108 | 0 percentage of participants |
| Follow-up Group-placebo | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 120 | 0 percentage of participants |
| Follow-up Group-placebo | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 144 | 0 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 120 | 0 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 108 | 0 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 95 | 0 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 144 | 0 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 144 | 0 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 120 | 0 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 108 | 0 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 95 | 0 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 95 | 0 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 144 | 0 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 108 | 0 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 120 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 120 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 144 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 108 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 95 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 108 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 120 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 144 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 | Week 95 | 0 percentage of participants |
Secondary
The Proportion of Patients With Both Negative HBeAg and HBeAb.
Time frame: week95,108,120,144
Population: intention to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Follow-up Group-placebo | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 95 | 33.3 percentage of paricipants |
| Follow-up Group-placebo | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 108 | 33.3 percentage of paricipants |
| Follow-up Group-placebo | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 120 | 0 percentage of paricipants |
| Follow-up Group-placebo | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 144 | 33.3 percentage of paricipants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 120 | 0 percentage of paricipants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 108 | 0 percentage of paricipants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 95 | 0 percentage of paricipants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 144 | 0 percentage of paricipants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 144 | 0 percentage of paricipants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 120 | 0 percentage of paricipants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 108 | 0 percentage of paricipants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 95 | 0 percentage of paricipants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 95 | 1.6 percentage of paricipants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 144 | 4.8 percentage of paricipants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 108 | 3.2 percentage of paricipants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 120 | 4.8 percentage of paricipants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 120 | 0 percentage of paricipants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 144 | 3.6 percentage of paricipants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 108 | 3.6 percentage of paricipants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 95 | 0 percentage of paricipants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 108 | 1.7 percentage of paricipants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 120 | 3.4 percentage of paricipants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 144 | 6.9 percentage of paricipants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBeAg and HBeAb. | Week 95 | 1.7 percentage of paricipants |
Secondary
The Proportion of Patients With Both Negative HBsAg and HBsAb.
Time frame: week95,108,120,144
Population: intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Follow-up Group-placebo | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 95 | 0 percentage of participants |
| Follow-up Group-placebo | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 108 | 0 percentage of participants |
| Follow-up Group-placebo | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 120 | 0 percentage of participants |
| Follow-up Group-placebo | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 144 | 0 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 120 | 0 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 108 | 0 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 95 | 0 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 144 | 0 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 144 | 0 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 120 | 0 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 108 | 0 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 95 | 0 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 95 | 0 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 144 | 0 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 108 | 0 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 120 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 120 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 144 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 108 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 95 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 108 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 120 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 144 | 0 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With Both Negative HBsAg and HBsAb. | Week 95 | 0 percentage of participants |
Secondary
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Time frame: week95,108,120,144
Population: intention to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Follow-up Group-placebo | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 95 | 100 percentage of participants |
| Follow-up Group-placebo | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 108 | 66.7 percentage of participants |
| Follow-up Group-placebo | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 120 | 33.3 percentage of participants |
| Follow-up Group-placebo | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 144 | 66.7 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 120 | 63.6 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 108 | 90.9 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 95 | 90.9 percentage of participants |
| Follow-up Group-εPA-44 600μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 144 | 63.6 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 144 | 100 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 120 | 44.4 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 108 | 55.6 percentage of participants |
| Follow-up Group-εPA-44 900μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 95 | 100 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 95 | 25.8 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 144 | 35.5 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 108 | 33.9 percentage of participants |
| εPA-44 900μg Group-placebo | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 120 | 32.3 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 120 | 23.6 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 144 | 30.9 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 108 | 25.5 percentage of participants |
| εPA-44 900μg Group-εPA-44 600μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 95 | 30.9 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 108 | 34.5 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 120 | 29.3 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 144 | 39.7 percentage of participants |
| εPA-44 900μg Group-εPA-44 900μg | The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit | Week 95 | 36.2 percentage of participants |