Trial Outcomes & Findings for Phase 2 Trial of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B (NCT NCT00869778)
NCT ID: NCT00869778
Last Updated: 2019-10-01
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
360 participants
Primary outcome timeframe
Endpoint(LOCF), up to 76 Weeks
Results posted on
2019-10-01
Participant Flow
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
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.
Participant milestones
| Measure |
εPA-44 900μg
Subcutaneous injection of εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
|
εPA-44 600μg
Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
|
Placebo 900μg
Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
120
|
|
Overall Study
COMPLETED
|
108
|
113
|
110
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
10
|
Reasons for withdrawal
| Measure |
εPA-44 900μg
Subcutaneous injection of εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
|
εPA-44 600μg
Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
|
Placebo 900μg
Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
5
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
5
|
3
|
5
|
|
Overall Study
Unblinding
|
1
|
0
|
0
|
Baseline Characteristics
Phase 2 Trial of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
εPA-44 900μg
n=120 Participants
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.
|
εPA-44 600μg+Placebo 300μg
n=120 Participants
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.
|
Placebo 900μg
n=120 Participants
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 7.28 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 8.56 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 7.30 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 7.93 • n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
21.92 kg/m^2
STANDARD_DEVIATION 2.992 • n=5 Participants
|
21.55 kg/m^2
STANDARD_DEVIATION 3.004 • n=7 Participants
|
21.99 kg/m^2
STANDARD_DEVIATION 2.643 • n=5 Participants
|
21.74 kg/m^2
STANDARD_DEVIATION 2.998 • n=4 Participants
|
PRIMARY outcome
Timeframe: Endpoint(LOCF), up to 76 WeeksPopulation: Intention-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 |
εPA-44 900μg
n=116 Participants
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.
|
εPA-44 600μg+Placebo 300μg
n=119 Participants
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.
|
Placebo 900μg
n=119 Participants
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
Percentage of Participants With HBeAg Seroconversion at Endpoint .
|
38.8 percentage of participants
|
28.6 percentage of participants
|
20.2 percentage of participants
|
SECONDARY outcome
Timeframe: serology response at week 12, 28, 32, 40, 52, 64, 76Population: Intent-to-treat population
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
Outcome measures
| Measure |
εPA-44 900μg
n=116 Participants
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.
|
εPA-44 600μg+Placebo 300μg
n=119 Participants
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.
|
Placebo 900μg
n=119 Participants
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76
Week 12
|
8.6 percentage of participants
|
7.6 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76
Week 28
|
13.8 percentage of participants
|
12.6 percentage of participants
|
7.6 percentage of participants
|
|
Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76
Week 32
|
16.4 percentage of participants
|
13.4 percentage of participants
|
9.2 percentage of participants
|
|
Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76
Week 40
|
22.4 percentage of participants
|
20.2 percentage of participants
|
10.9 percentage of participants
|
|
Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76
Week 52
|
25.9 percentage of participants
|
22.7 percentage of participants
|
10.9 percentage of participants
|
|
Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76
Week 64
|
31.9 percentage of participants
|
24.4 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76
Week 76
|
37.9 percentage of participants
|
28.6 percentage of participants
|
18.5 percentage of participants
|
SECONDARY outcome
Timeframe: week 12, 28, 32, 40, 52, 64, 76Population: Intent-to-treat population
Outcome measures
| Measure |
εPA-44 900μg
n=116 Participants
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.
|
εPA-44 600μg+Placebo 300μg
n=119 Participants
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.
|
Placebo 900μg
n=119 Participants
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg 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
|
29.3 percentage of participants
|
33.6 percentage of participants
|
27.7 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;
Week 28
|
42.2 percentage of participants
|
48.7 percentage of participants
|
39.5 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;
Week 32
|
50.0 percentage of participants
|
55.5 percentage of participants
|
45.4 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;
Week 40
|
49.1 percentage of participants
|
55.5 percentage of participants
|
47.9 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;
Week 52
|
48.3 percentage of participants
|
53.8 percentage of participants
|
36.1 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;
Week 64
|
54.3 percentage of participants
|
61.3 percentage of participants
|
43.7 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;
Week 76
|
62.1 percentage of participants
|
64.7 percentage of participants
|
55.5 percentage of participants
|
SECONDARY outcome
Timeframe: week 12, 28, 32, 40, 52, 64, 76Population: Intent-to-treat population
Outcome measures
| Measure |
εPA-44 900μg
n=116 Participants
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.
|
εPA-44 600μg+Placebo 300μg
n=119 Participants
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.
|
Placebo 900μg
n=119 Participants
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
Week 4
|
9.5 percentage of participants
|
4.2 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
Week 8
|
12.9 percentage of participants
|
8.4 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
Week 12
|
19 percentage of participants
|
10.9 percentage of participants
|
13.4 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
Week 28
|
32.8 percentage of participants
|
20.2 percentage of participants
|
20.2 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
Week 32
|
32.8 percentage of participants
|
29.4 percentage of participants
|
18.5 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
Week 40
|
39.7 percentage of participants
|
31.9 percentage of participants
|
26.9 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
Week 52
|
36.2 percentage of participants
|
33.6 percentage of participants
|
21.8 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
Week 64
|
44 percentage of participants
|
38.7 percentage of participants
|
26.9 percentage of participants
|
|
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
Week 76
|
48.3 percentage of participants
|
37.8 percentage of participants
|
34.5 percentage of participants
|
SECONDARY outcome
Timeframe: at week 12, 28, 32, 40, 52, 64, 76.Population: Intent-to-treat population
Outcome measures
| Measure |
εPA-44 900μg
n=116 Participants
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.
|
εPA-44 600μg+Placebo 300μg
n=119 Participants
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.
|
Placebo 900μg
n=119 Participants
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
The Proportion of Patients With Both Negative HBeAg and HBeAb;
Week 12
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients With Both Negative HBeAg and HBeAb;
Week 28
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients With Both Negative HBeAg and HBeAb;
Week 32
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients With Both Negative HBeAg and HBeAb;
Week 40
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients With Both Negative HBeAg and HBeAb;
Week 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients With Both Negative HBeAg and HBeAb;
Week 64
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Proportion of Patients With Both Negative HBeAg and HBeAb;
Week 76
|
0.9 percentage of participants
|
0.8 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: at week 12, 28, 32, 40, 52, 64, 76.Population: Intent-to-treat population
Outcome measures
| Measure |
εPA-44 900μg
n=116 Participants
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.
|
εPA-44 600μg+Placebo 300μg
n=119 Participants
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.
|
Placebo 900μg
n=119 Participants
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
The Proportion of Patients With Positive Anti-HBe
Week 12
|
15.5 percentage of participants
|
14.3 percentage of participants
|
10.9 percentage of participants
|
|
The Proportion of Patients With Positive Anti-HBe
Week 28
|
25.9 percentage of participants
|
26.1 percentage of participants
|
18.5 percentage of participants
|
|
The Proportion of Patients With Positive Anti-HBe
Week 32
|
29.3 percentage of participants
|
27.7 percentage of participants
|
20.2 percentage of participants
|
|
The Proportion of Patients With Positive Anti-HBe
Week 40
|
31.0 percentage of participants
|
31.1 percentage of participants
|
22.7 percentage of participants
|
|
The Proportion of Patients With Positive Anti-HBe
Week 52
|
31.0 percentage of participants
|
34.5 percentage of participants
|
18.5 percentage of participants
|
|
The Proportion of Patients With Positive Anti-HBe
Week 64
|
36.2 percentage of participants
|
38.7 percentage of participants
|
23.5 percentage of participants
|
|
The Proportion of Patients With Positive Anti-HBe
Week 76
|
44.0 percentage of participants
|
37.0 percentage of participants
|
29.4 percentage of participants
|
SECONDARY outcome
Timeframe: at week 12, 28, 32, 40, 52, 64, 76.Population: Intent-to-treat population
Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values
Outcome measures
| Measure |
εPA-44 900μg
n=116 Participants
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.
|
εPA-44 600μg+Placebo 300μg
n=119 Participants
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.
|
Placebo 900μg
n=119 Participants
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
Change From Baseline by Visit for HBeAg Titer
Week 12
|
11.5 IU/mL
Standard Deviation 1250.38
|
-460.2 IU/mL
Standard Deviation 2650.77
|
-278.7 IU/mL
Standard Deviation 1561.74
|
|
Change From Baseline by Visit for HBeAg Titer
Week 28
|
-285.4 IU/mL
Standard Deviation 1343.17
|
-725.2 IU/mL
Standard Deviation 2774.22
|
-450.3 IU/mL
Standard Deviation 1673.79
|
|
Change From Baseline by Visit for HBeAg Titer
Week 32
|
-339.3 IU/mL
Standard Deviation 1442.08
|
-768.3 IU/mL
Standard Deviation 2778.79
|
-471.3 IU/mL
Standard Deviation 1692.48
|
|
Change From Baseline by Visit for HBeAg Titer
Week 40
|
-407.4 IU/mL
Standard Deviation 1523.68
|
-737.6 IU/mL
Standard Deviation 2944.83
|
-496.8 IU/mL
Standard Deviation 1721.17
|
|
Change From Baseline by Visit for HBeAg Titer
Week 52
|
-410.0 IU/mL
Standard Deviation 1637.26
|
-788.0 IU/mL
Standard Deviation 3015.94
|
-458.9 IU/mL
Standard Deviation 1791.04
|
|
Change From Baseline by Visit for HBeAg Titer
Week 64
|
-271.8 IU/mL
Standard Deviation 1267.02
|
-822.8 IU/mL
Standard Deviation 3124.94
|
-563.4 IU/mL
Standard Deviation 1800.32
|
|
Change From Baseline by Visit for HBeAg Titer
Week 76
|
-327.5 IU/mL
Standard Deviation 1286.44
|
-947.4 IU/mL
Standard Deviation 3231.94
|
-629.3 IU/mL
Standard Deviation 1846.07
|
SECONDARY outcome
Timeframe: week 12, 28, 32, 40, 52, 64, 76Population: Intent-to-treat population
Outcome measures
| Measure |
εPA-44 900μg
n=116 Participants
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.
|
εPA-44 600μg+Placebo 300μg
n=119 Participants
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.
|
Placebo 900μg
n=119 Participants
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;
Week 12
|
12.9 percentage of participants
|
19.3 percentage of participants
|
13.4 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;
Week 28
|
29.3 percentage of participants
|
31.1 percentage of participants
|
24.4 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;
Week 32
|
28.4 percentage of participants
|
33.6 percentage of participants
|
24.4 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;
Week 40
|
35.3 percentage of participants
|
40.3 percentage of participants
|
26.1 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;
Week 52
|
37.9 percentage of participants
|
42.9 percentage of participants
|
23.5 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;
Week 64
|
41.4 percentage of participants
|
47.9 percentage of participants
|
31.1 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;
Week 76
|
50.0 percentage of participants
|
48.7 percentage of participants
|
40.3 percentage of participants
|
SECONDARY outcome
Timeframe: week 12, 28, 32, 40, 52, 64, 76Population: Intent-to-treat population
Outcome measures
| Measure |
εPA-44 900μg
n=116 Participants
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.
|
εPA-44 600μg+Placebo 300μg
n=119 Participants
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.
|
Placebo 900μg
n=119 Participants
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;
Week 12
|
7.8 percentage of participants
|
10.9 percentage of participants
|
5.9 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;
Week 28
|
17.2 percentage of participants
|
17.6 percentage of participants
|
11.8 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;
Week 32
|
21.6 percentage of participants
|
20.2 percentage of participants
|
10.1 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;
Week 40
|
23.3 percentage of participants
|
24.4 percentage of participants
|
12.6 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;
Week 52
|
29.3 percentage of participants
|
26.9 percentage of participants
|
11.8 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;
Week 64
|
30.2 percentage of participants
|
31.1 percentage of participants
|
19.3 percentage of participants
|
|
The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;
Week 76
|
42.2 percentage of participants
|
32.8 percentage of participants
|
27.7 percentage of participants
|
SECONDARY outcome
Timeframe: week 12, 28, 32, 40, 52, 64, 76Population: Intent-to-treat population
Measuring the change in value of each visit viewpoints HBV DNA titers decreased compared with baseline values
Outcome measures
| Measure |
εPA-44 900μg
n=116 Participants
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.
|
εPA-44 600μg+Placebo 300μg
n=119 Participants
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.
|
Placebo 900μg
n=119 Participants
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
Change From Baseline by Visit for Serum HBV DNA
Week 12
|
-176000000 IU/mL
Standard Deviation 927000000
|
-336000000 IU/mL
Standard Deviation 1195000000
|
-129000000 IU/mL
Standard Deviation 293200000
|
|
Change From Baseline by Visit for Serum HBV DNA
Week 28
|
-213000000 IU/mL
Standard Deviation 919000000
|
-362000000 IU/mL
Standard Deviation 1217000000
|
-172000000 IU/mL
Standard Deviation 299000000
|
|
Change From Baseline by Visit for Serum HBV DNA
Week 32
|
-226000000 IU/mL
Standard Deviation 925700000
|
-372000000 IU/mL
Standard Deviation 1218000000
|
-172000000 IU/mL
Standard Deviation 308500000
|
|
Change From Baseline by Visit for Serum HBV DNA
Week 40
|
-229000000 IU/mL
Standard Deviation 917000000
|
-387000000 IU/mL
Standard Deviation 1236000000
|
-181000000 IU/mL
Standard Deviation 322700000
|
|
Change From Baseline by Visit for Serum HBV DNA
Week 52
|
-219000000 IU/mL
Standard Deviation 917500000
|
-373000000 IU/mL
Standard Deviation 1263000000
|
-140000000 IU/mL
Standard Deviation 311600000
|
|
Change From Baseline by Visit for Serum HBV DNA
Week 64
|
-229000000 IU/mL
Standard Deviation 932100000
|
-362000000 IU/mL
Standard Deviation 1045000000
|
-168000000 IU/mL
Standard Deviation 340500000
|
|
Change From Baseline by Visit for Serum HBV DNA
Week 76
|
-276000000 IU/mL
Standard Deviation 870500000
|
-408000000 IU/mL
Standard Deviation 1303000000
|
-207000000 IU/mL
Standard Deviation 350200000
|
Adverse Events
εPA-44 900μg
Serious events: 3 serious events
Other events: 56 other events
Deaths: 0 deaths
εPA-44 600μg+Placebo 300μg
Serious events: 2 serious events
Other events: 66 other events
Deaths: 0 deaths
Placebo 900μg
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
εPA-44 900μg
n=120 participants at risk
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.
|
εPA-44 600μg+Placebo 300μg
n=120 participants at risk
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.
|
Placebo 900μg
n=120 participants at risk
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
Gastrointestinal disorders
Acute gastric perforation
|
0.83%
1/120 • Number of events 1 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
|
Hepatobiliary disorders
Exacerbation of chronic hepatitis B
|
0.83%
1/120 • Number of events 1 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal bronchogenic cyst
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
0.83%
1/120 • Number of events 1 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
|
Hepatobiliary disorders
Abnormal liver function
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
0.83%
1/120 • Number of events 1 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
|
Musculoskeletal and connective tissue disorders
Right leg fibula fracture
|
0.83%
1/120 • Number of events 1 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
|
Hepatobiliary disorders
Acute exacerbation of hepatitis
|
0.83%
1/120 • Number of events 1 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
0.83%
1/120 • Number of events 1 • Adverse Events After Dosing（0-76week）
|
Other adverse events
| Measure |
εPA-44 900μg
n=120 participants at risk
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.
|
εPA-44 600μg+Placebo 300μg
n=120 participants at risk
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.
|
Placebo 900μg
n=120 participants at risk
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Local injection site reactions
|
5.0%
6/120 • Adverse Events After Dosing（0-76week）
|
10.8%
13/120 • Adverse Events After Dosing（0-76week）
|
5.0%
6/120 • Adverse Events After Dosing（0-76week）
|
|
Skin and subcutaneous tissue disorders
Injection site pain
|
2.5%
3/120 • Adverse Events After Dosing（0-76week）
|
3.3%
4/120 • Adverse Events After Dosing（0-76week）
|
5.0%
6/120 • Adverse Events After Dosing（0-76week）
|
|
Skin and subcutaneous tissue disorders
Injection site pruritus
|
2.5%
3/120 • Adverse Events After Dosing（0-76week）
|
4.2%
5/120 • Adverse Events After Dosing（0-76week）
|
5.8%
7/120 • Adverse Events After Dosing（0-76week）
|
|
Infections and infestations
Upper respiratory tract infection
|
10.8%
13/120 • Adverse Events After Dosing（0-76week）
|
8.3%
10/120 • Adverse Events After Dosing（0-76week）
|
7.5%
9/120 • Adverse Events After Dosing（0-76week）
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
15/120 • Adverse Events After Dosing（0-76week）
|
16.7%
20/120 • Adverse Events After Dosing（0-76week）
|
10.8%
13/120 • Adverse Events After Dosing（0-76week）
|
|
General disorders
weakness
|
7.5%
9/120 • Adverse Events After Dosing（0-76week）
|
5.0%
6/120 • Adverse Events After Dosing（0-76week）
|
4.2%
5/120 • Adverse Events After Dosing（0-76week）
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
6/120 • Adverse Events After Dosing（0-76week）
|
4.2%
5/120 • Adverse Events After Dosing（0-76week）
|
3.3%
4/120 • Adverse Events After Dosing（0-76week）
|
|
Metabolism and nutrition disorders
Loss of appetite
|
1.7%
2/120 • Adverse Events After Dosing（0-76week）
|
3.3%
4/120 • Adverse Events After Dosing（0-76week）
|
0.83%
1/120 • Adverse Events After Dosing（0-76week）
|
|
Reproductive system and breast disorders
Oropharyngeal pain
|
3.3%
4/120 • Adverse Events After Dosing（0-76week）
|
2.5%
3/120 • Adverse Events After Dosing（0-76week）
|
0.83%
1/120 • Adverse Events After Dosing（0-76week）
|
|
Reproductive system and breast disorders
Coughing
|
0.83%
1/120 • Adverse Events After Dosing（0-76week）
|
1.7%
2/120 • Adverse Events After Dosing（0-76week）
|
3.3%
4/120 • Adverse Events After Dosing（0-76week）
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
3.3%
4/120 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
1.7%
2/120 • Adverse Events After Dosing（0-76week）
|
|
Infections and infestations
Female genital infections
|
1.7%
2/120 • Adverse Events After Dosing（0-76week）
|
3.3%
4/120 • Adverse Events After Dosing（0-76week）
|
0.83%
1/120 • Adverse Events After Dosing（0-76week）
|
|
Gastrointestinal disorders
Upper abdominal pain
|
2.5%
3/120 • Adverse Events After Dosing（0-76week）
|
3.3%
4/120 • Adverse Events After Dosing（0-76week）
|
0.83%
1/120 • Adverse Events After Dosing（0-76week）
|
|
Gastrointestinal disorders
Right upper quadrant pain
|
4.2%
5/120 • Adverse Events After Dosing（0-76week）
|
1.7%
2/120 • Adverse Events After Dosing（0-76week）
|
0.00%
0/120 • Adverse Events After Dosing（0-76week）
|
|
Gastrointestinal disorders
nausea
|
2.5%
3/120 • Adverse Events After Dosing（0-76week）
|
3.3%
4/120 • Adverse Events After Dosing（0-76week）
|
3.3%
4/120 • Adverse Events After Dosing（0-76week）
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.3%
4/120 • Adverse Events After Dosing（0-76week）
|
0.83%
1/120 • Adverse Events After Dosing（0-76week）
|
0.83%
1/120 • Adverse Events After Dosing（0-76week）
|
|
Skin and subcutaneous tissue disorders
Injection site swelling
|
0.83%
1/120 • Adverse Events After Dosing（0-76week）
|
4.2%
5/120 • Adverse Events After Dosing（0-76week）
|
2.5%
3/120 • Adverse Events After Dosing（0-76week）
|
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