Trial Outcomes & Findings for A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B (NCT NCT00922207)
NCT ID: NCT00922207
Last Updated: 2017-04-10
Results Overview
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
280 participants
Primary outcome timeframe
Week 100
Results posted on
2017-04-10
Participant Flow
Participant milestones
| Measure |
Peg-IFN-Alfa-2a + Adefovir
Participants received adefovir (Hepsera) 10 milligrams (mg) tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peginterferon alfa-2a (peg-IFN-alfa-2a; Pegasys) 180 micrograms (µg) subcutaneous (SC) injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
Participants received entecavir (Baraclude) 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
95
|
94
|
|
Overall Study
COMPLETED
|
85
|
88
|
90
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
4
|
Reasons for withdrawal
| Measure |
Peg-IFN-Alfa-2a + Adefovir
Participants received adefovir (Hepsera) 10 milligrams (mg) tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peginterferon alfa-2a (peg-IFN-alfa-2a; Pegasys) 180 micrograms (µg) subcutaneous (SC) injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
Participants received entecavir (Baraclude) 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event/Intercurrent Illness
|
3
|
0
|
0
|
|
Overall Study
Insufficient Therapeutic Response
|
0
|
0
|
1
|
|
Overall Study
Violation of Selection Criteria at Entry
|
0
|
1
|
0
|
|
Overall Study
Refused Treatment/Did Not Cooperate
|
1
|
0
|
0
|
|
Overall Study
Withdrew Consent
|
2
|
5
|
2
|
|
Overall Study
Abnormality of Laboratory Test
|
0
|
1
|
1
|
Baseline Characteristics
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
Peg-IFN-Alfa-2a + Adefovir
n=91 Participants
Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
n=95 Participants
Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
n=94 Participants
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
38.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
199 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 100Population: ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).
Outcome measures
| Measure |
Peg-IFN-Alfa-2a + Adefovir
n=84 Participants
Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
n=88 Participants
Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
n=91 Participants
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment
|
27.4 percentage of participants
Interval 17.8 to 36.9
|
29.5 percentage of participants
Interval 20.0 to 39.1
|
36.3 percentage of participants
Interval 26.4 to 46.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.
HBV DNA (copies per milliliter \[copies/mL\]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.
Outcome measures
| Measure |
Peg-IFN-Alfa-2a + Adefovir
n=91 Participants
Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
n=95 Participants
Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
n=94 Participants
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Baseline (n=91,95,94)
|
8.65 copies/mL
Standard Deviation 1.03
|
8.30 copies/mL
Standard Deviation 1.21
|
8.41 copies/mL
Standard Deviation 0.96
|
|
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 4 (n=90,94,92)
|
-2.15 copies/mL
Standard Deviation 0.94
|
-2.76 copies/mL
Standard Deviation 0.97
|
-0.23 copies/mL
Standard Deviation 0.88
|
|
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 8 (n=90,94,92)
|
-1.87 copies/mL
Standard Deviation 1.40
|
-3.58 copies/mL
Standard Deviation 1.12
|
-1.32 copies/mL
Standard Deviation 1.32
|
|
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 16 (n=90,94,92)
|
-2.14 copies/mL
Standard Deviation 1.72
|
-3.77 copies/mL
Standard Deviation 1.53
|
-2.13 copies/mL
Standard Deviation 1.93
|
|
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 28 (n=90,94,92)
|
-2.34 copies/mL
Standard Deviation 1.90
|
-3.07 copies/mL
Standard Deviation 1.88
|
-2.84 copies/mL
Standard Deviation 2.14
|
|
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 40 (n=90,94,92)
|
-2.61 copies/mL
Standard Deviation 2.11
|
-2.97 copies/mL
Standard Deviation 2.11
|
-3.27 copies/mL
Standard Deviation 2.25
|
|
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 52 (n=90,94,92)
|
-2.75 copies/mL
Standard Deviation 2.29
|
-2.81 copies/mL
Standard Deviation 2.43
|
-3.32 copies/mL
Standard Deviation 2.48
|
|
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 64 (n=90,94,92)
|
-1.87 copies/mL
Standard Deviation 2.26
|
-1.37 copies/mL
Standard Deviation 2.31
|
-2.11 copies/mL
Standard Deviation 2.42
|
|
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 76 (n=90,94,92)
|
-1.91 copies/mL
Standard Deviation 2.24
|
-1.39 copies/mL
Standard Deviation 2.46
|
-2.20 copies/mL
Standard Deviation 2.57
|
|
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 88 (n=90,94,92)
|
-1.78 copies/mL
Standard Deviation 2.36
|
-1.39 copies/mL
Standard Deviation 2.42
|
-2.30 copies/mL
Standard Deviation 2.34
|
|
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 100 (n=90,94,92)
|
-2.00 copies/mL
Standard Deviation 2.35
|
-1.78 copies/mL
Standard Deviation 2.41
|
-2.17 copies/mL
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.
Outcome measures
| Measure |
Peg-IFN-Alfa-2a + Adefovir
n=91 Participants
Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
n=95 Participants
Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
n=94 Participants
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Were HBeAg Negative
Baseline (n=91,95,94)
|
3.3 percentage of participants
Interval 0.0 to 7.0
|
2.1 percentage of participants
Interval 0.0 to 5.0
|
0.0 percentage of participants
The 95 percent (%) confidence interval (CV) could not be calculated as no participant had response at this time-point.
|
|
Percentage of Participants Who Were HBeAg Negative
Week 4 (n=90,94,92)
|
5.6 percentage of participants
Interval 0.8 to 10.3
|
4.3 percentage of participants
Interval 0.2 to 8.3
|
1.1 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants Who Were HBeAg Negative
Week 8 (n=90,94,92)
|
6.7 percentage of participants
Interval 1.5 to 11.8
|
6.4 percentage of participants
Interval 1.4 to 11.3
|
4.3 percentage of participants
Interval 0.2 to 8.5
|
|
Percentage of Participants Who Were HBeAg Negative
Week 16 (n=90,94,92)
|
6.7 percentage of participants
Interval 1.5 to 11.8
|
8.5 percentage of participants
Interval 2.9 to 14.2
|
10.9 percentage of participants
Interval 4.5 to 17.2
|
|
Percentage of Participants Who Were HBeAg Negative
Week 28 (n=90,94,92)
|
11.1 percentage of participants
Interval 4.6 to 17.6
|
10.6 percentage of participants
Interval 4.4 to 16.9
|
16.3 percentage of participants
Interval 8.8 to 23.9
|
|
Percentage of Participants Who Were HBeAg Negative
Week 40 (n=90,94,92)
|
18.9 percentage of participants
Interval 10.8 to 27.0
|
18.1 percentage of participants
Interval 10.3 to 25.9
|
22.8 percentage of participants
Interval 14.2 to 31.4
|
|
Percentage of Participants Who Were HBeAg Negative
Week 52 (n=90,94,92)
|
22.2 percentage of participants
Interval 13.6 to 30.8
|
22.3 percentage of participants
Interval 13.9 to 30.8
|
29.3 percentage of participants
Interval 20.0 to 38.7
|
|
Percentage of Participants Who Were HBeAg Negative
Week 64 (n=90,92,92)
|
24.4 percentage of participants
Interval 15.6 to 33.3
|
25.0 percentage of participants
Interval 16.2 to 33.8
|
31.5 percentage of participants
Interval 22.0 to 41.0
|
|
Percentage of Participants Who Were HBeAg Negative
Week 76 (n=88,88,92)
|
25.0 percentage of participants
Interval 16.0 to 34.0
|
28.4 percentage of participants
Interval 19.0 to 37.8
|
37.0 percentage of participants
Interval 27.1 to 46.8
|
|
Percentage of Participants Who Were HBeAg Negative
Week 88 (n=86,87,90)
|
27.9 percentage of participants
Interval 18.4 to 37.4
|
27.6 percentage of participants
Interval 18.2 to 37.0
|
34.4 percentage of participants
Interval 24.6 to 44.3
|
|
Percentage of Participants Who Were HBeAg Negative
Week 100 (n=84,87,91)
|
28.6 percentage of participants
Interval 18.9 to 38.2
|
32.2 percentage of participants
Interval 22.4 to 42.0
|
37.4 percentage of participants
Interval 27.4 to 47.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.
Outcome measures
| Measure |
Peg-IFN-Alfa-2a + Adefovir
n=91 Participants
Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
n=95 Participants
Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
n=94 Participants
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
|---|---|---|---|
|
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Baseline (n=91,95,94)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Week 4 (n=90,94,92)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Week 8 (n=90,94,92)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Week 16 (n=90,94,92)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Week 28 (n=90,94,92)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Week 40 (n=90,94,92)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Week 52 (n=90,94,92)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Week 64 (n=90,92,92)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Week 76 (n=88,88,92)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Week 88 (n=86,87,90)
|
1.2 percentage of participants
|
0.0 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Week 100 (n=84,87,91)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.
The normal range for ALT is 10 to 40 international units per liter (IU/L).
Outcome measures
| Measure |
Peg-IFN-Alfa-2a + Adefovir
n=91 Participants
Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
n=95 Participants
Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
n=94 Participants
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
|---|---|---|---|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Baseline (n=91,95,94)
|
4.4 percentage of participants
|
3.2 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 6 (n=90,93,92)
|
4.4 percentage of participants
|
5.4 percentage of participants
|
6.5 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 12 (n=90,93,92)
|
15.6 percentage of participants
|
17.2 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 16 (n=90,93,92)
|
21.1 percentage of participants
|
24.7 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 22 (n=90,93,92)
|
25.6 percentage of participants
|
34.4 percentage of participants
|
22.8 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 28 (n=90,93,92)
|
26.7 percentage of participants
|
30.1 percentage of participants
|
23.9 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 34 (n=90,93,92)
|
26.7 percentage of participants
|
34.4 percentage of participants
|
32.6 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 40 (n=90,93,92)
|
30.0 percentage of participants
|
39.8 percentage of participants
|
32.6 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 46 (n=90,93,92)
|
30.0 percentage of participants
|
41.9 percentage of participants
|
33.7 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 52 (n=90,93,92)
|
33.3 percentage of participants
|
34.4 percentage of participants
|
32.6 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 64 (n=90,92,92)
|
32.2 percentage of participants
|
37.0 percentage of participants
|
42.4 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 76 (n=89,89,92)
|
43.8 percentage of participants
|
38.2 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 88 (n=86,88,91)
|
32.6 percentage of participants
|
33.0 percentage of participants
|
48.4 percentage of participants
|
|
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Week 100 (n=84,88,91)
|
36.9 percentage of participants
|
40.9 percentage of participants
|
49.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.
Outcome measures
| Measure |
Peg-IFN-Alfa-2a + Adefovir
n=91 Participants
Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
n=95 Participants
Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
n=94 Participants
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
|---|---|---|---|
|
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Baseline (n=91,95,94)
|
3.97 International Units/milliliter (IU/mL)
Standard Deviation 0.72
|
3.76 International Units/milliliter (IU/mL)
Standard Deviation 0.83
|
3.84 International Units/milliliter (IU/mL)
Standard Deviation 0.71
|
|
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 4 (n=90,94,92)
|
-0.26 International Units/milliliter (IU/mL)
Standard Deviation 0.48
|
-0.18 International Units/milliliter (IU/mL)
Standard Deviation 0.44
|
-0.02 International Units/milliliter (IU/mL)
Standard Deviation 0.33
|
|
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 8 (n=90,94,92)
|
-0.33 International Units/milliliter (IU/mL)
Standard Deviation 0.78
|
-0.31 International Units/milliliter (IU/mL)
Standard Deviation 0.58
|
-0.25 International Units/milliliter (IU/mL)
Standard Deviation 0.56
|
|
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 16 (n=90,94,92)
|
-0.40 International Units/milliliter (IU/mL)
Standard Deviation 0.78
|
-0.49 International Units/milliliter (IU/mL)
Standard Deviation 0.74
|
-0.48 International Units/milliliter (IU/mL)
Standard Deviation 0.83
|
|
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 28 (n=90,94,92)
|
-0.61 International Units/milliliter (IU/mL)
Standard Deviation 0.96
|
-0.68 International Units/milliliter (IU/mL)
Standard Deviation 0.98
|
-0.70 International Units/milliliter (IU/mL)
Standard Deviation 1.08
|
|
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 40 (n=90,94,92)
|
-0.71 International Units/milliliter (IU/mL)
Standard Deviation 1.09
|
-0.67 International Units/milliliter (IU/mL)
Standard Deviation 1.04
|
-0.82 International Units/milliliter (IU/mL)
Standard Deviation 1.27
|
|
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 52 (n=90,94,92)
|
-0.78 International Units/milliliter (IU/mL)
Standard Deviation 1.27
|
-0.69 International Units/milliliter (IU/mL)
Standard Deviation 1.11
|
-0.88 International Units/milliliter (IU/mL)
Standard Deviation 1.41
|
|
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 64 (n=90,94,92)
|
-0.67 International Units/milliliter (IU/mL)
Standard Deviation 1.18
|
-0.54 International Units/milliliter (IU/mL)
Standard Deviation 1.07
|
-0.67 International Units/milliliter (IU/mL)
Standard Deviation 1.21
|
|
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 76 (n=90,94,92)
|
-0.58 International Units/milliliter (IU/mL)
Standard Deviation 0.95
|
-0.45 International Units/milliliter (IU/mL)
Standard Deviation 1.01
|
-0.53 International Units/milliliter (IU/mL)
Standard Deviation 1.19
|
|
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 88 (n=90,94,92)
|
-0.50 International Units/milliliter (IU/mL)
Standard Deviation 1.11
|
-0.44 International Units/milliliter (IU/mL)
Standard Deviation 0.90
|
-0.62 International Units/milliliter (IU/mL)
Standard Deviation 1.20
|
|
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Change at Week 100 (n=90,94,92)
|
-0.41 International Units/milliliter (IU/mL)
Standard Deviation 0.75
|
-0.60 International Units/milliliter (IU/mL)
Standard Deviation 1.15
|
-0.56 International Units/milliliter (IU/mL)
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.
Combined response was defined as having negative HBeAg, HBV DNA less than (\<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).
Outcome measures
| Measure |
Peg-IFN-Alfa-2a + Adefovir
n=91 Participants
Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
n=95 Participants
Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
n=94 Participants
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Combined Response
Baseline (n=91,95,94)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Combined Response
Week 16 (n=90,93,92)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Combined Response
Week 28 (n=90,93,92)
|
0.0 percentage of participants
|
1.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Combined Response
Week 40 (n=90,93,92)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Combined Response
Week 52 (n=90,93,92)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Combined Response
Week 64 (n=90,92,92)
|
2.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Combined Response
Week 76 (n=88,89,92)
|
3.4 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Combined Response
Week 88 (n=86,88,91)
|
3.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Combined Response
Week 100 (n=84,88,91)
|
2.4 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Peg-IFN-Alfa-2a + Adefovir
Serious events: 7 serious events
Other events: 85 other events
Deaths: 0 deaths
Peg-IFN-Alfa-2a + Entecavir
Serious events: 12 serious events
Other events: 83 other events
Deaths: 0 deaths
Peg-IFN-Alfa-2a + Placebo
Serious events: 7 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peg-IFN-Alfa-2a + Adefovir
n=91 participants at risk
Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
n=94 participants at risk
Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
n=93 participants at risk
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
|---|---|---|---|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.1%
1/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Cellulitis
|
1.1%
1/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Hepatitis B
|
2.2%
2/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Overdose
|
1.1%
1/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
4.3%
4/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
1.1%
1/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Calculus urethral
|
1.1%
1/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Upper gastrointestinal heamorrhage
|
1.1%
1/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
Peg-IFN-Alfa-2a + Adefovir
n=91 participants at risk
Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Entecavir
n=94 participants at risk
Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
Peg-IFN-Alfa-2a + Placebo
n=93 participants at risk
Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
|
|---|---|---|---|
|
General disorders
Chills
|
6.6%
6/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
4.3%
4/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
General disorders
Fatigue
|
14.3%
13/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
12.8%
12/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
16.1%
15/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
General disorders
Influenza like illnes
|
3.3%
3/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
5.3%
5/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
3.2%
3/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
General disorders
Injection site pain
|
4.4%
4/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
5.3%
5/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
4.3%
4/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
General disorders
Malaise
|
5.5%
5/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
3.2%
3/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
5.4%
5/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
22.0%
20/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
20.2%
19/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
22.6%
21/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
5.5%
5/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
2.1%
2/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Influenza
|
4.4%
4/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
8.5%
8/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
2.2%
2/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
8/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
7.4%
7/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
10.8%
10/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.6%
6/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
11.7%
11/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
15.1%
14/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
14/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
18.1%
17/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
19.4%
18/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Investigations
Weight decreased
|
5.5%
5/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
9.6%
9/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
3.2%
3/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.8%
8/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
7.4%
7/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
10.8%
10/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
7/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
6.4%
6/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
4.3%
4/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.7%
17/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
13.8%
13/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
19.4%
18/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
8.8%
8/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
14.9%
14/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
8.6%
8/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
23.1%
21/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
18.1%
17/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
21.5%
20/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
6.6%
6/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
4.3%
4/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
11.8%
11/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.6%
6/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
8.5%
8/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
8.6%
8/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.3%
3/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
3.2%
3/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
6.5%
6/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
7/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
9.6%
9/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
4.3%
4/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
5/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
4.3%
4/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
6/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
5.3%
5/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
6.5%
6/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
14/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
9.6%
9/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
14.0%
13/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
3.3%
3/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
0.00%
0/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
8.6%
8/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
4.4%
4/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
6.4%
6/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
3.2%
3/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
7/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
10.6%
10/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
8.6%
8/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
6/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
9.6%
9/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
7.5%
7/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.4%
4/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
2.1%
2/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
5.4%
5/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.3%
23/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
28.7%
27/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
26.9%
25/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.7%
7/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
1.1%
1/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
5.4%
5/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
12.1%
11/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
14.9%
14/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
16.1%
15/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.0%
10/91 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
10.6%
10/94 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
7.5%
7/93 • Baseline up to Week 100
Safety analysis population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER