Trial Outcomes & Findings for Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients (NCT NCT01326546)
NCT ID: NCT01326546
Last Updated: 2019-06-26
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
378 participants
Primary outcome timeframe
48 weeks
Results posted on
2019-06-26
Participant Flow
Participant milestones
| Measure |
Therapeutic HBV Vaccine+Entecavir
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
Therapeutic HBV vaccine: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
entecavir: 0.5mg,per day,oral intake.
|
Placebo+Entecavir
Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
entecavir: 0.5mg,per day,oral intake.
placebo: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
|
|---|---|---|
|
Overall Study
STARTED
|
189
|
189
|
|
Overall Study
COMPLETED
|
172
|
176
|
|
Overall Study
NOT COMPLETED
|
17
|
13
|
Reasons for withdrawal
| Measure |
Therapeutic HBV Vaccine+Entecavir
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
Therapeutic HBV vaccine: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
entecavir: 0.5mg,per day,oral intake.
|
Placebo+Entecavir
Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
entecavir: 0.5mg,per day,oral intake.
placebo: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
7
|
|
Overall Study
Protocol Violation
|
3
|
4
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
Baseline Characteristics
Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients
Baseline characteristics by cohort
| Measure |
Therapeutic HBV Vaccine+Entecavir
n=189 Participants
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
Therapeutic HBV vaccine: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
entecavir: 0.5mg,per day,oral intake.
|
Placebo+Entecavir
n=188 Participants
Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
entecavir: 0.5mg,per day,oral intake.
placebo: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 9.52 • n=93 Participants
|
28.3 years
STANDARD_DEVIATION 7.91 • n=4 Participants
|
28.7 years
STANDARD_DEVIATION 8.75 • n=27 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
148 Participants
n=93 Participants
|
142 Participants
n=4 Participants
|
290 Participants
n=27 Participants
|
|
BMI
|
21.61 kg/m^2
STANDARD_DEVIATION 2.707 • n=93 Participants
|
21.78 kg/m^2
STANDARD_DEVIATION 3.014 • n=4 Participants
|
21.7 kg/m^2
STANDARD_DEVIATION 2.861 • n=27 Participants
|
PRIMARY outcome
Timeframe: 48 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 |
Therapeutic HBV Vaccine+Entecavir
n=189 Participants
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
Therapeutic HBV vaccine: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
entecavir: 0.5mg,per day,oral intake.
|
Placebo+Entecavir
n=188 Participants
Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
entecavir: 0.5mg,per day,oral intake.
placebo: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
|
|---|---|---|
|
Percentage of Participants With HBeAg Seroconversion at Week 48
|
21 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 96 weeksSerological response at every observation time: serological conversion rate of HBeAg, negative conversion rate of HBeAg, and change of HBeAg.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 96 weeksVirological response at every observation time: the proportion of patients with serum HBV DNA level reduction to undetectable level, decreased amount of serum HBV DNA compared with the baseline value, and HBV DNA load decrease 2 log scales or HBV DNA level \<1.72×104 IU/ml.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 96 weeksBiochemistry response at every observation time, mean the ALT level reduce to normal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 weeksHistological response at week 72, mean histological score limited reduce 2 (reduced score 2-5), and no fiber deterioration compare with before treatment.
Outcome measures
Outcome data not reported
Adverse Events
Therapeutic HBV Vaccine+Entecavir
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo+Entecavir
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Therapeutic HBV Vaccine+Entecavir
n=189 participants at risk
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
Therapeutic HBV vaccine: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
entecavir: 0.5mg,per day,oral intake.
|
Placebo+Entecavir
n=189 participants at risk
Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
entecavir: 0.5mg,per day,oral intake.
placebo: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
|
|---|---|---|
|
Immune system disorders
Anaphylactic shock
|
0.53%
1/189 • Number of events 1 • After doing(0-96week)
|
0.00%
0/189 • After doing(0-96week)
|
Other adverse events
| Measure |
Therapeutic HBV Vaccine+Entecavir
n=189 participants at risk
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
Therapeutic HBV vaccine: Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
entecavir: 0.5mg,per day,oral intake.
|
Placebo+Entecavir
n=189 participants at risk
Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
entecavir: 0.5mg,per day,oral intake.
placebo: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
|
|---|---|---|
|
Infections and infestations
upper respiratory infection
|
5.3%
10/189 • After doing(0-96week)
|
5.3%
10/189 • After doing(0-96week)
|
|
Infections and infestations
nasopharyngitis
|
11.1%
21/189 • After doing(0-96week)
|
12.7%
24/189 • After doing(0-96week)
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
2/189 • After doing(0-96week)
|
4.2%
8/189 • After doing(0-96week)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
7/189 • After doing(0-96week)
|
3.2%
6/189 • After doing(0-96week)
|
|
Nervous system disorders
Dizziness
|
2.1%
4/189 • After doing(0-96week)
|
3.2%
6/189 • After doing(0-96week)
|
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