Trial Outcomes & Findings for A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV) (NCT NCT01095835)
NCT ID: NCT01095835
Last Updated: 2016-11-03
Results Overview
Combined response was defined as alanine aminotransferase (ALT) normalization plus lowering of hepatitis B virus (HBV) deoxyribo nucleic acid (DNA) levels to \<20,000 copies/mL (\<3,400 IU/mL) and was measured at the end of the 48-week follow-up period. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
131 participants
Primary outcome timeframe
At the end of the 48-week follow-up period at Week 144
Results posted on
2016-11-03
Participant Flow
The Intent-to-Treat (ITT) population (n=128) included all participants randomized who received at least one dose of study medication. Three enrolled participants (total enrolled n=131) did not receive any study medication and were therefore excluded from the ITT population.The ITT population is reported in the Participant Flow.
Participant milestones
| Measure |
PEG-IFN48
Treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
52
|
25
|
|
Overall Study
COMPLETED
|
41
|
40
|
17
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
8
|
Reasons for withdrawal
| Measure |
PEG-IFN48
Treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
6
|
6
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
|
Overall Study
Non study compliance
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
Baseline Characteristics
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
Baseline characteristics by cohort
| Measure |
PEG-IFN48
n=51 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
n=25 Participants
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At the end of the 48-week follow-up period at Week 144Population: The ITT population included all participants randomized who received at least one dose of study medication.
Combined response was defined as alanine aminotransferase (ALT) normalization plus lowering of hepatitis B virus (HBV) deoxyribo nucleic acid (DNA) levels to \<20,000 copies/mL (\<3,400 IU/mL) and was measured at the end of the 48-week follow-up period. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.
Outcome measures
| Measure |
PEG-IFN48
n=51 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
n=25 Participants
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period
|
11.8 percentage of participants
|
25.0 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: At end of treatment at Week 48 or 96 depending on the study armPopulation: The ITT population included all participants randomized who received at least one dose of study medication.
Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to \<20,000 copies/mL (\<3,400 IU/mL). In case of missing end of treatment measurements, the next available post-treatment value was used.
Outcome measures
| Measure |
PEG-IFN48
n=51 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
n=25 Participants
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Percentage of Participants Achieving the Combined Response at the End of Treatment
|
29.4 percentage of participants
|
38.5 percentage of participants
|
32.0 percentage of participants
|
SECONDARY outcome
Timeframe: At the end of 24 weeks of follow-up at Week 120Population: The ITT population included all participants randomized who received at least one dose of study medication.
Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to \<20,000 copies/mL (\<3,400 IU/mL). In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used.
Outcome measures
| Measure |
PEG-IFN48
n=51 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
n=25 Participants
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up
|
23.5 percentage of participants
|
28.8 percentage of participants
|
24.0 percentage of participants
|
SECONDARY outcome
Timeframe: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144Population: The ITT population included all participants randomized who received at least one dose of study medication.
Combined response was defined here as ALT normalization plus lowering HBV-DNA levels to a cutt-off \<2,000 IU/mL. In case of missing end of treatment measurements, the next available post-treatment value was used. In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.
Outcome measures
| Measure |
PEG-IFN48
n=51 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
n=25 Participants
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL
End of treatment
|
29.4 percentage of participants
|
38.5 percentage of participants
|
28.0 percentage of participants
|
|
Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL
48 weeks of follow-up
|
11.8 percentage of participants
|
23.1 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL
24 weeks of follow-up
|
21.6 percentage of participants
|
26.9 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: At the end of the 48-week follow-up period at Week 144Population: The ITT population included all participants randomized who received at least one dose of study medication.
Histological response was defined as an improvement by \>/= 2 in the Necroinflammatory Grading and/or by an improvement by \>/= 1 score in Fibrosis Staging according to Ishak. Necroinflammatory Grading ranges 0-14 and is the combined score for necrosis, range 0-10 and inflammation, range 0-4. The participant is scored for only one inflammatory condition. A higher score indicates worse condition. Fibrosis Staging according to Ishak ranges 0-6 and a higher score indicates greater fibrosis.
Outcome measures
| Measure |
PEG-IFN48
n=51 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
n=25 Participants
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Percentage of Participants Achieving Histological Response
|
13.7 percentage of participants
|
5.8 percentage of participants
|
8.0 percentage of participants
|
SECONDARY outcome
Timeframe: At the end of treatment at Week 48 or 96 depending on the study armPopulation: The ITT population included all participants randomized who received at least one dose of study medication. Baseline values are included for those participants for whom a baseline value was measured. Change from baseline values includes only those participants with both a baseline value and a value for the summarized time period.
Outcome measures
| Measure |
PEG-IFN48
n=51 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
n=25 Participants
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment
Baseline (n=51, 51, 25)
|
9642.6 IU/mL
Standard Deviation 19756.4
|
7229.8 IU/mL
Standard Deviation 6459.0
|
8981.0 IU/mL
Standard Deviation 7728.5
|
|
Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment
Change from baseline (n=44, 44, 20)
|
-2801.1 IU/mL
Standard Deviation 14691.2
|
-2282.1 IU/mL
Standard Deviation 6007.1
|
-3121.2 IU/mL
Standard Deviation 7128.9
|
SECONDARY outcome
Timeframe: At the end of the treatment period at Week 96Population: The ITT population for arm PEG-IFN+LAM96 included all participants randomized to PEG-IFN+LAM96 who received at least one dose of study medication.
Lamivudine resistance mutations were assessed by detection of the following mutations: rtL80V, rtL80I, rtV173G, rtV173L, rtL180M, rtA181T, rtA181V, rtM204V, rtM204I and rtN236T.
Outcome measures
| Measure |
PEG-IFN48
n=25 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy
|
0 percentage of participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144Population: The ITT population included all participants randomized who received at least one dose of study medication.
Outcome measures
| Measure |
PEG-IFN48
n=51 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
n=25 Participants
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Percentage of Participants With ALT Normalization
End of treatment
|
35.3 percentage of participants
|
40.4 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With ALT Normalization
24 weeks of follow-up
|
45.1 percentage of participants
|
46.2 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With ALT Normalization
48 weeks of follow-up
|
35.3 percentage of participants
|
34.6 percentage of participants
|
36.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144Population: The ITT population included all participants randomized who received at least one dose of study medication.
Outcome measures
| Measure |
PEG-IFN48
n=51 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
n=25 Participants
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL
24 weeks of follow-up: HBV-DNA < 2,000 IU/mL
|
21.6 percentage of participants
|
28.8 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL
48 weeks of follow-up: HBV-DNA < 2,000 IU/mL
|
11.8 percentage of participants
|
28.8 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL
End of treatment: HBV-DNA < 3,400 IU/mL
|
60.8 percentage of participants
|
67.3 percentage of participants
|
76.0 percentage of participants
|
|
Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL
24 weeks of follow-up: HBV-DNA < 3,400 IU/mL
|
23.5 percentage of participants
|
30.8 percentage of participants
|
24.0 percentage of participants
|
|
Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL
48 weeks of follow-up: HBV-DNA < 3,400 IU/mL
|
11.8 percentage of participants
|
30.8 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL
End of treatment: HBV-DNA < 2,000 IU/mL
|
58.8 percentage of participants
|
67.3 percentage of participants
|
72.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144Population: The ITT population included all participants randomized who received at least one dose of study medication.
HBV-DNA limit \< 6 IU/mL was defined as below quantification.
Outcome measures
| Measure |
PEG-IFN48
n=51 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
n=25 Participants
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Percentage of Participants With HBV-DNA Below Limit of Quantification
End of treatment
|
17.6 percentage of participants
|
30.8 percentage of participants
|
24.0 percentage of participants
|
|
Percentage of Participants With HBV-DNA Below Limit of Quantification
48 weeks of follow-up
|
2.0 percentage of participants
|
7.7 percentage of participants
|
8.0 percentage of participants
|
|
Percentage of Participants With HBV-DNA Below Limit of Quantification
24 weeks of follow-up
|
0.0 percentage of participants
|
7.7 percentage of participants
|
4.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144Population: The ITT population included all participants randomized who received at least one dose of study medication.
This outcome measure presents percentage of participants with a combined response of HBsAg \< 5 IU/mL and anti-HBs positive. Positive anti-HBs represents antibodies produced against Hepatitis B Surface Antigen (HBsAg) and is an indication of recovery and immunity from HBV infection.
Outcome measures
| Measure |
PEG-IFN48
n=51 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 Participants
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN+LAM96
n=25 Participants
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion
End of treatment
|
2.0 percentage of participants
|
3.8 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion
24 weeks of follow-up
|
0.0 percentage of participants
|
5.8 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion
48 weeks of follow-up
|
0.0 percentage of participants
|
7.7 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
PEG-IFN48
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
PEG-IFN96
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
PEG-IFN + LAM96
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-IFN48
n=50 participants at risk
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 participants at risk
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN + LAM96
n=25 participants at risk
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
1.9%
1/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
General disorders
Pyrexia
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Infections and infestations
Cytomegalovirus infection
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Nervous system disorders
Facial palsy
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
1.9%
1/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
1.9%
1/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
Other adverse events
| Measure |
PEG-IFN48
n=50 participants at risk
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
|
PEG-IFN96
n=52 participants at risk
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
|
PEG-IFN + LAM96
n=25 participants at risk
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
5/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
7.7%
4/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
5.8%
3/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.0%
12/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
17.3%
9/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
12.0%
3/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.0%
6/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
11.5%
6/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
1.9%
1/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
4/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
7.7%
4/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
12.0%
3/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
2/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
7.7%
4/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
5.8%
3/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
7.7%
4/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
5/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
3.8%
2/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
General disorders
Asthenia
|
34.0%
17/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
36.5%
19/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
44.0%
11/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
General disorders
Influenza like illness
|
18.0%
9/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
19.2%
10/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
16.0%
4/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
General disorders
Pyrexia
|
36.0%
18/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
36.5%
19/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
32.0%
8/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Infections and infestations
Pharyngitis
|
6.0%
3/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
3.8%
2/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
1.9%
1/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Infections and infestations
Urinary tract infection
|
6.0%
3/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
1.9%
1/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
2/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
7.7%
4/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Investigations
Platelet count decreased
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
7.7%
4/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
5.8%
3/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.0%
2/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
11.5%
6/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
6/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
11.5%
6/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
12.0%
3/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
3/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
11.5%
6/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.0%
7/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
15.4%
8/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
16.0%
4/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Nervous system disorders
Headache
|
26.0%
13/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
15.4%
8/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
28.0%
7/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Nervous system disorders
Sciatica
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
5.8%
3/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Psychiatric disorders
Anxiety
|
8.0%
4/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
9.6%
5/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Psychiatric disorders
Insomnia
|
8.0%
4/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
5.8%
3/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
5.8%
3/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
3/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
11.5%
6/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.0%
3/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
5.8%
3/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
4.0%
1/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
5/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
11.5%
6/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
12.0%
3/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
5.8%
3/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
1.9%
1/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
8.0%
2/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
|
Vascular disorders
Hypertension
|
2.0%
1/50 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
7.7%
4/52 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
0.00%
0/25 • Up to 48 weeks after last study treatment dose (up to Week 144)
The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800-821-8590
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