Trial Outcomes & Findings for Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B (NCT NCT02862106)
NCT ID: NCT02862106
Last Updated: 2019-08-20
Results Overview
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
209 participants
Primary outcome timeframe
Endpoint (LOCF), up to 144 weeks
Results posted on
2019-08-20
Participant Flow
Participants completed the first stage(0-76weeks),enrolled at 9 sites in the China. The first participant was screened on 19 November 2011.
209 participants entered the second stage of the study , and comprise the Safety Analysis Set and the Full Analysis Set
Participant milestones
| Measure |
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
|
Follow-up Group
Do not give any intervention, follow-up observation only
|
|---|---|---|
|
Overall Study
STARTED
|
183
|
26
|
|
Overall Study
COMPLETED
|
145
|
20
|
|
Overall Study
NOT COMPLETED
|
38
|
6
|
Reasons for withdrawal
| Measure |
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
|
Follow-up Group
Do not give any intervention, follow-up observation only
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Protocol Violation
|
16
|
1
|
|
Overall Study
Lost to Follow-up
|
15
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Subjects moved to other city
|
1
|
0
|
Baseline Characteristics
Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
Follow-up Group-placebo
n=3 Participants
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
n=12 Participants
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
n=10 Participants
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
|
εPA-44 900μg Group-placebo
n=64 Participants
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
|
εPA-44 900μg Group-εPA-44 600μg
n=56 Participants
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
n=58 Participants
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
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
203 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
32.7 years
STANDARD_DEVIATION 6.03 • n=5 Participants
|
25.2 years
STANDARD_DEVIATION 4.39 • n=7 Participants
|
25.8 years
STANDARD_DEVIATION 8.02 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 7.56 • n=4 Participants
|
29.6 years
STANDARD_DEVIATION 9.14 • n=21 Participants
|
29.4 years
STANDARD_DEVIATION 7.61 • n=8 Participants
|
29.4 years
STANDARD_DEVIATION 7.96 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
153 Participants
n=8 Participants
|
|
BMI
|
22.69 kg/m^2
STANDARD_DEVIATION 4.043 • n=5 Participants
|
21.23 kg/m^2
STANDARD_DEVIATION 2.181 • n=7 Participants
|
21.42 kg/m^2
STANDARD_DEVIATION 2.601 • n=5 Participants
|
21.95 kg/m^2
STANDARD_DEVIATION 2.615 • n=4 Participants
|
21.76 kg/m^2
STANDARD_DEVIATION 3.273 • n=21 Participants
|
22.12 kg/m^2
STANDARD_DEVIATION 2.792 • n=8 Participants
|
21.89 kg/m^2
STANDARD_DEVIATION 2.835 • n=8 Participants
|
PRIMARY outcome
Timeframe: Endpoint (LOCF), up to 144 weeksPopulation: Intent-to-treat population
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
Outcome measures
| Measure |
Follow-up Group-placebo
n=3 Participants
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
n=11 Participants
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
n=9 Participants
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
|
εPA-44 900μg Group-placebo
n=62 Participants
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 600μg
n=55 Participants
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
n=58 Participants
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
|
|---|---|---|---|---|---|---|
|
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period
|
66.7 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
38.7 percentage of participants
|
40 percentage of participants
|
34.5 percentage of participants
|
SECONDARY outcome
Timeframe: week95,108,120,144Population: Intention to treat population
Outcome measures
| Measure |
Follow-up Group-placebo
n=3 Participants
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
n=11 Participants
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
n=9 Participants
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
|
εPA-44 900μg Group-placebo
n=62 Participants
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 600μg
n=55 Participants
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
n=58 Participants
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
|
|---|---|---|---|---|---|---|
|
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
Week 95
|
66.7 percentage of paricipant
|
100 percentage of paricipant
|
100 percentage of paricipant
|
25.8 percentage of paricipant
|
21.8 percentage of paricipant
|
34.5 percentage of paricipant
|
|
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
Week 108
|
33.3 percentage of paricipant
|
100 percentage of paricipant
|
55.6 percentage of paricipant
|
32.3 percentage of paricipant
|
32.7 percentage of paricipant
|
34.5 percentage of paricipant
|
|
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
Week 120
|
33.3 percentage of paricipant
|
72.7 percentage of paricipant
|
44.4 percentage of paricipant
|
29.0 percentage of paricipant
|
30.9 percentage of paricipant
|
25.9 percentage of paricipant
|
|
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
Week 144
|
33.3 percentage of paricipant
|
81.8 percentage of paricipant
|
100 percentage of paricipant
|
37.1 percentage of paricipant
|
32.7 percentage of paricipant
|
27.6 percentage of paricipant
|
SECONDARY outcome
Timeframe: week95,108,120,144Population: intention to treat population
Outcome measures
| Measure |
Follow-up Group-placebo
n=3 Participants
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
n=11 Participants
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
n=9 Participants
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
|
εPA-44 900μg Group-placebo
n=62 Participants
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 600μg
n=55 Participants
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
n=58 Participants
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
|
|---|---|---|---|---|---|---|
|
The Proportion of Patients With Both Negative HBeAg and HBeAb.
Week 95
|
33.3 percentage of paricipants
|
0 percentage of paricipants
|
0 percentage of paricipants
|
1.6 percentage of paricipants
|
0 percentage of paricipants
|
1.7 percentage of paricipants
|
|
The Proportion of Patients With Both Negative HBeAg and HBeAb.
Week 108
|
33.3 percentage of paricipants
|
0 percentage of paricipants
|
0 percentage of paricipants
|
3.2 percentage of paricipants
|
3.6 percentage of paricipants
|
1.7 percentage of paricipants
|
|
The Proportion of Patients With Both Negative HBeAg and HBeAb.
Week 120
|
0 percentage of paricipants
|
0 percentage of paricipants
|
0 percentage of paricipants
|
4.8 percentage of paricipants
|
0 percentage of paricipants
|
3.4 percentage of paricipants
|
|
The Proportion of Patients With Both Negative HBeAg and HBeAb.
Week 144
|
33.3 percentage of paricipants
|
0 percentage of paricipants
|
0 percentage of paricipants
|
4.8 percentage of paricipants
|
3.6 percentage of paricipants
|
6.9 percentage of paricipants
|
SECONDARY outcome
Timeframe: week95,108,120,144Population: intention to treat population
Outcome measures
| Measure |
Follow-up Group-placebo
n=3 Participants
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
n=11 Participants
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
n=9 Participants
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
|
εPA-44 900μg Group-placebo
n=62 Participants
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 600μg
n=55 Participants
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
n=58 Participants
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
|
|---|---|---|---|---|---|---|
|
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
Week 95
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
Week 108
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
Week 120
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
Week 144
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: week95,108,120,144Population: intent-to-treat population
Outcome measures
| Measure |
Follow-up Group-placebo
n=3 Participants
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
n=11 Participants
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
n=9 Participants
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
|
εPA-44 900μg Group-placebo
n=62 Participants
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 600μg
n=55 Participants
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
n=58 Participants
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
|
|---|---|---|---|---|---|---|
|
The Proportion of Patients With Both Negative HBsAg and HBsAb.
Week 95
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients With Both Negative HBsAg and HBsAb.
Week 108
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients With Both Negative HBsAg and HBsAb.
Week 120
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients With Both Negative HBsAg and HBsAb.
Week 144
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: week95,108,120,144Population: intention to treat population
Outcome measures
| Measure |
Follow-up Group-placebo
n=3 Participants
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
n=11 Participants
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
n=9 Participants
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
|
εPA-44 900μg Group-placebo
n=62 Participants
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 600μg
n=55 Participants
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
n=58 Participants
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
|
|---|---|---|---|---|---|---|
|
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Week 95
|
100 percentage of participants
|
90.9 percentage of participants
|
100 percentage of participants
|
25.8 percentage of participants
|
30.9 percentage of participants
|
36.2 percentage of participants
|
|
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Week 108
|
66.7 percentage of participants
|
90.9 percentage of participants
|
55.6 percentage of participants
|
33.9 percentage of participants
|
25.5 percentage of participants
|
34.5 percentage of participants
|
|
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Week 120
|
33.3 percentage of participants
|
63.6 percentage of participants
|
44.4 percentage of participants
|
32.3 percentage of participants
|
23.6 percentage of participants
|
29.3 percentage of participants
|
|
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Week 144
|
66.7 percentage of participants
|
63.6 percentage of participants
|
100 percentage of participants
|
35.5 percentage of participants
|
30.9 percentage of participants
|
39.7 percentage of participants
|
SECONDARY outcome
Timeframe: week95,108,120,144Population: intention to treat population
Outcome measures
| Measure |
Follow-up Group-placebo
n=3 Participants
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
n=11 Participants
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
n=9 Participants
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
|
εPA-44 900μg Group-placebo
n=62 Participants
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 600μg
n=55 Participants
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
n=58 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline by Visit for Serum HBV DNA
Week 95 decreases from baseline
|
6.0 log_10 IU/mL
Standard Deviation 0.67
|
5.1 log_10 IU/mL
Standard Deviation 1.23
|
5.6 log_10 IU/mL
Standard Deviation 0.92
|
2.8 log_10 IU/mL
Standard Deviation 1.83
|
2.7 log_10 IU/mL
Standard Deviation 2.18
|
2.9 log_10 IU/mL
Standard Deviation 2.34
|
|
Change From Baseline by Visit for Serum HBV DNA
Baseline values of log
|
8.1 log_10 IU/mL
Standard Deviation 0.64
|
7.6 log_10 IU/mL
Standard Deviation 0.97
|
7.5 log_10 IU/mL
Standard Deviation 1.1
|
7.8 log_10 IU/mL
Standard Deviation 0.88
|
8.1 log_10 IU/mL
Standard Deviation 0.9
|
8.0 log_10 IU/mL
Standard Deviation 0.99
|
|
Change From Baseline by Visit for Serum HBV DNA
week 108 decreases from baseline
|
6.3 log_10 IU/mL
Standard Deviation 0.14
|
5.2 log_10 IU/mL
Standard Deviation 1.24
|
5.4 log_10 IU/mL
Standard Deviation 0.71
|
3.0 log_10 IU/mL
Standard Deviation 2.10
|
3.1 log_10 IU/mL
Standard Deviation 2.17
|
3.2 log_10 IU/mL
Standard Deviation 2.40
|
|
Change From Baseline by Visit for Serum HBV DNA
week 120 decreases from baseline
|
5.5 log_10 IU/mL
Standard Deviation 0.97
|
5.2 log_10 IU/mL
Standard Deviation 0.99
|
5.9 log_10 IU/mL
Standard Deviation 0.83
|
3.0 log_10 IU/mL
Standard Deviation 2.19
|
3.3 log_10 IU/mL
Standard Deviation 1.94
|
2.8 log_10 IU/mL
Standard Deviation 2.66
|
|
Change From Baseline by Visit for Serum HBV DNA
week 144 decreases from baseline
|
5.6 log_10 IU/mL
Standard Deviation 0.34
|
5.1 log_10 IU/mL
Standard Deviation 1.09
|
5.6 log_10 IU/mL
Standard Deviation 1.21
|
3.2 log_10 IU/mL
Standard Deviation 2.27
|
4.1 log_10 IU/mL
Standard Deviation 1.77
|
3.3 log_10 IU/mL
Standard Deviation 2.69
|
SECONDARY outcome
Timeframe: week95,108,120,144Population: intent to treat population
Outcome measures
| Measure |
Follow-up Group-placebo
n=3 Participants
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
n=11 Participants
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
n=9 Participants
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
|
εPA-44 900μg Group-placebo
n=62 Participants
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 600μg
n=55 Participants
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
n=58 Participants
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
|
|---|---|---|---|---|---|---|
|
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
|
100 percentage of participants
|
100 percentage of participants
|
59.7 percentage of participants
|
52.7 percentage of participants
|
60.3 percentage of participants
|
|
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
|
100 percentage of participants
|
55.6 percentage of participants
|
61.3 percentage of participants
|
60.0 percentage of participants
|
60.3 percentage of participants
|
|
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
|
72.7 percentage of participants
|
44.4 percentage of participants
|
54.8 percentage of participants
|
58.2 percentage of participants
|
43.1 percentage of participants
|
|
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
|
81.8 percentage of participants
|
100 percentage of participants
|
61.2 percentage of participants
|
58.2 percentage of participants
|
55.2 percentage of participants
|
SECONDARY outcome
Timeframe: week95,108,120,144Population: intend to treat population
Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values
Outcome measures
| Measure |
Follow-up Group-placebo
n=3 Participants
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
n=11 Participants
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
n=9 Participants
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
|
εPA-44 900μg Group-placebo
n=62 Participants
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 600μg
n=55 Participants
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
n=58 Participants
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
|
|---|---|---|---|---|---|---|
|
Change From Baseline by Vsit for HBeAg Titer.
baseline of HBeAg titers
|
1276.5 IU/ML
Standard Deviation 1447.33
|
758.5 IU/ML
Standard Deviation 1287.52
|
285.9 IU/ML
Standard Deviation 411.9
|
681.9 IU/ML
Standard Deviation 658.52
|
958.3 IU/ML
Standard Deviation 929.45
|
880.9 IU/ML
Standard Deviation 1368.65
|
|
Change From Baseline by Vsit for HBeAg Titer.
Week 95 decreases from baseline
|
-1276.3 IU/ML
Standard Deviation 1447.33
|
-758.3 IU/ML
Standard Deviation 1287.52
|
-285.7 IU/ML
Standard Deviation 411.9
|
-435.8 IU/ML
Standard Deviation 685.25
|
-617.1 IU/ML
Standard Deviation 913.09
|
-550.7 IU/ML
Standard Deviation 1834.16
|
|
Change From Baseline by Vsit for HBeAg Titer.
week 108 decreases from baseline
|
-446.3 IU/ML
Standard Deviation 237.59
|
-758.3 IU/ML
Standard Deviation 1287.52
|
-38.9 IU/ML
Standard Deviation 49.73
|
-476.8 IU/ML
Standard Deviation 728.21
|
-807.0 IU/ML
Standard Deviation 1011.18
|
-602.9 IU/ML
Standard Deviation 1755.50
|
|
Change From Baseline by Vsit for HBeAg Titer.
week 120 decreases from baseline
|
-446.3 IU/ML
Standard Deviation 237.64
|
-979.9 IU/ML
Standard Deviation 1463.54
|
-314.4 IU/ML
Standard Deviation 576.36
|
-500.7 IU/ML
Standard Deviation 654.06
|
-769.4 IU/ML
Standard Deviation 1017.49
|
-486.3 IU/ML
Standard Deviation 927.24
|
|
Change From Baseline by Vsit for HBeAg Titer.
week 144 decreases from baseline
|
-446.3 IU/ML
Standard Deviation 237.59
|
-923.9 IU/ML
Standard Deviation 1379.30
|
-285.7 IU/ML
Standard Deviation 411.9
|
-546.3 IU/ML
Standard Deviation 629.66
|
-788.4 IU/ML
Standard Deviation 887.7
|
-691.5 IU/ML
Standard Deviation 1708.44
|
Adverse Events
Follow-up Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
εPA-44 900μg Group
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Follow-up Group
n=25 participants at risk
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
|
εPA-44 900μg Group
n=178 participants at risk
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
|
|---|---|---|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/25
|
0.56%
1/178 • Number of events 1
|
|
Renal and urinary disorders
Chronic nephritis
|
0.00%
0/25
|
0.56%
1/178 • Number of events 1
|
|
Infections and infestations
Severe chronic hepatitis B
|
0.00%
0/25
|
1.1%
2/178 • Number of events 2
|
|
Infections and infestations
Acute exacerbation of Chronic hepatitis B
|
0.00%
0/25
|
0.56%
1/178 • Number of events 1
|
Other adverse events
| Measure |
Follow-up Group
n=25 participants at risk
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
|
εPA-44 900μg Group
n=178 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection site pruritus
|
0.00%
0/25
|
1.1%
2/178
|
|
Skin and subcutaneous tissue disorders
Injection site swelling
|
0.00%
0/25
|
1.1%
2/178
|
|
Skin and subcutaneous tissue disorders
Injection site erythema
|
0.00%
0/25
|
1.1%
2/178
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/25
|
4.5%
8/178
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25
|
2.8%
5/178
|
|
General disorders
weakness
|
0.00%
0/25
|
1.7%
3/178
|
|
General disorders
fever
|
4.0%
1/25
|
0.56%
1/178
|
|
General disorders
ALT increased
|
0.00%
0/25
|
1.7%
3/178
|
|
Investigations
AST increased
|
0.00%
0/25
|
1.1%
2/178
|
|
Investigations
Leukocytes in urine positive
|
0.00%
0/25
|
1.1%
2/178
|
|
Investigations
Elevated transaminase
|
0.00%
0/25
|
1.1%
2/178
|
|
Nervous system disorders
insomnia
|
0.00%
0/25
|
1.1%
2/178
|
|
Gastrointestinal disorders
Mouth ulcers
|
4.0%
1/25
|
1.1%
2/178
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/25
|
1.7%
3/178
|
|
Gastrointestinal disorders
Gum pain
|
0.00%
0/25
|
1.1%
2/178
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/25
|
1.1%
2/178
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators can't publish articles relevant to the study unless the sponsor permits.
- Publication restrictions are in place
Restriction type: OTHER