Trial Outcomes & Findings for A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both (NCT NCT00962871)
NCT ID: NCT00962871
Last Updated: 2016-02-08
Results Overview
An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
Results posted on
2016-02-08
Participant Flow
The study was conducted between 30 July 2009 to 01 February 2012 and recruited participants from 4 centers in New Zealand (1), Taiwan (1), and Singapore (2).
A total of 65 participants were screened of which 30 participants were randomized. 35 participants failed the screening evaluation mainly due to inability to meet the inclusion criteria and consent withdrawal.
Participant milestones
| Measure |
Tenofovir 300 mg
Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg
Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
PEG-IFN Alfa-2a 360 μg
Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
Delayed Treatment
Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
12
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
Baseline characteristics by cohort
| Measure |
Tenofovir 300 mg
n=6 Participants
Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg
n=6 Participants
Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
PEG-IFN Alfa-2a 360 μg
n=12 Participants
Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
Delayed Treatment
n=6 Participants
Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 11.09 • n=5 Participants
|
28 years
STANDARD_DEVIATION 3.16 • n=7 Participants
|
28.5 years
STANDARD_DEVIATION 5.40 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 3.87 • n=4 Participants
|
30 years
STANDARD_DEVIATION 7.26 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)Population: All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.
An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.
Outcome measures
| Measure |
Tenofovir 300 mg
n=6 Participants
Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg
n=6 Participants
Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
PEG-IFN Alfa-2a 360 μg
n=12 Participants
Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
Delayed Treatment
n=6 Participants
Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Viral Quantitative e Antibody
Day 5
|
-0.02 Cut-off index (C.O.I.)
Standard Deviation 0.049
|
0.04 Cut-off index (C.O.I.)
Standard Deviation 0.255
|
-0.15 Cut-off index (C.O.I.)
Standard Deviation 0.150
|
0.07 Cut-off index (C.O.I.)
Standard Deviation 0.066
|
|
Mean Change From Baseline in Viral Quantitative e Antibody
Day 1
|
0.07 Cut-off index (C.O.I.)
Standard Deviation 0.162
|
0.15 Cut-off index (C.O.I.)
Standard Deviation 0.234
|
0.02 Cut-off index (C.O.I.)
Standard Deviation 0.063
|
0.03 Cut-off index (C.O.I.)
Standard Deviation 0.062
|
|
Mean Change From Baseline in Viral Quantitative e Antibody
Day 3
|
0.00 Cut-off index (C.O.I.)
Standard Deviation 0.089
|
0.03 Cut-off index (C.O.I.)
Standard Deviation 0.267
|
-0.13 Cut-off index (C.O.I.)
Standard Deviation 0.119
|
-0.10 Cut-off index (C.O.I.)
Standard Deviation 0.274
|
|
Mean Change From Baseline in Viral Quantitative e Antibody
Day 8
|
-0.05 Cut-off index (C.O.I.)
Standard Deviation 0.051
|
0.07 Cut-off index (C.O.I.)
Standard Deviation 0.223
|
-0.09 Cut-off index (C.O.I.)
Standard Deviation 0.155
|
0.04 Cut-off index (C.O.I.)
Standard Deviation 0.069
|
|
Mean Change From Baseline in Viral Quantitative e Antibody
Day 10
|
-0.13 Cut-off index (C.O.I.)
Standard Deviation 0.146
|
0.04 Cut-off index (C.O.I.)
Standard Deviation 0.247
|
-0.12 Cut-off index (C.O.I.)
Standard Deviation 0.175
|
0.03 Cut-off index (C.O.I.)
Standard Deviation 0.127
|
|
Mean Change From Baseline in Viral Quantitative e Antibody
Day 14
|
-0.02 Cut-off index (C.O.I.)
Standard Deviation 0.147
|
0.03 Cut-off index (C.O.I.)
Standard Deviation 0.259
|
-0.13 Cut-off index (C.O.I.)
Standard Deviation 0.267
|
-0.00 Cut-off index (C.O.I.)
Standard Deviation 0.162
|
|
Mean Change From Baseline in Viral Quantitative e Antibody
Week 3
|
NA Cut-off index (C.O.I.)
Standard Deviation NA
Only participants with both a baseline value and a value particular time point were summarized
|
0.01 Cut-off index (C.O.I.)
Standard Deviation 0.219
|
-0.22 Cut-off index (C.O.I.)
Standard Deviation 0.282
|
NA Cut-off index (C.O.I.)
Standard Deviation NA
Only participants with both a baseline value and a value particular time point were summarized
|
|
Mean Change From Baseline in Viral Quantitative e Antibody
Week 4
|
-0.04 Cut-off index (C.O.I.)
Standard Deviation 0.302
|
-0.05 Cut-off index (C.O.I.)
Standard Deviation 0.370
|
-0.29 Cut-off index (C.O.I.)
Standard Deviation 0.322
|
-0.40 Cut-off index (C.O.I.)
Standard Deviation 0.521
|
|
Mean Change From Baseline in Viral Quantitative e Antibody
Week 6
|
NA Cut-off index (C.O.I.)
Standard Deviation NA
Only participants with both a baseline value and a value particular time point were summarized
|
-0.21 Cut-off index (C.O.I.)
Standard Deviation 0.785
|
-0.31 Cut-off index (C.O.I.)
Standard Deviation 0.481
|
NA Cut-off index (C.O.I.)
Standard Deviation NA
Only participants with both a baseline value and a value particular time point were summarized
|
SECONDARY outcome
Timeframe: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)Population: All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.
An acute virologic response was determined by change from baseline in HBV-DNA log10.
Outcome measures
| Measure |
Tenofovir 300 mg
n=6 Participants
Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg
n=6 Participants
Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
PEG-IFN Alfa-2a 360 μg
n=12 Participants
Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
Delayed Treatment
n=6 Participants
Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
|
|---|---|---|---|---|
|
Mean Change From Baseline in HBV-DNA log10
Week 6
|
NA IU/mL
Standard Deviation NA
Only participants with both a baseline value and a value particular time point were summarized
|
-1.73 IU/mL
Standard Deviation 1.462
|
-1.30 IU/mL
Standard Deviation 0.978
|
NA IU/mL
Standard Deviation NA
Only participants with both a baseline value and a value particular time point were summarized
|
|
Mean Change From Baseline in HBV-DNA log10
Day 2
|
-0.61 IU/mL
Standard Deviation 0.330
|
-0.46 IU/mL
Standard Deviation 0.196
|
-0.14 IU/mL
Standard Deviation 0.179
|
0.08 IU/mL
Standard Deviation 0.110
|
|
Mean Change From Baseline in HBV-DNA log10
Day 3
|
-1.04 IU/mL
Standard Deviation 0.342
|
-0.75 IU/mL
Standard Deviation 0.480
|
-0.46 IU/mL
Standard Deviation 0.222
|
0.04 IU/mL
Standard Deviation 0.064
|
|
Mean Change From Baseline in HBV-DNA log10
Day 5
|
-1.53 IU/mL
Standard Deviation 0.306
|
-1.45 IU/mL
Standard Deviation 0.551
|
-0.64 IU/mL
Standard Deviation 0.239
|
-0.06 IU/mL
Standard Deviation 0.120
|
|
Mean Change From Baseline in HBV-DNA log10
Day 8
|
-2.16 IU/mL
Standard Deviation 0.244
|
-1.93 IU/mL
Standard Deviation 0.645
|
-0.54 IU/mL
Standard Deviation 0.226
|
-0.07 IU/mL
Standard Deviation 0.316
|
|
Mean Change From Baseline in HBV-DNA log10
Day 10
|
-2.37 IU/mL
Standard Deviation 0.167
|
-2.11 IU/mL
Standard Deviation 0.735
|
-0.57 IU/mL
Standard Deviation 0.299
|
-0.09 IU/mL
Standard Deviation 0.493
|
|
Mean Change From Baseline in HBV-DNA log10
Day 14
|
-2.7 IU/mL
Standard Deviation 0.142
|
-2.46 IU/mL
Standard Deviation 0.800
|
-0.61 IU/mL
Standard Deviation 0.521
|
-0.26 IU/mL
Standard Deviation 0.573
|
|
Mean Change From Baseline in HBV-DNA log10
Week 3
|
-0.76 IU/mL
Standard Deviation 0.518
|
-2.88 IU/mL
Standard Deviation 0.702
|
-0.79 IU/mL
Standard Deviation 0.622
|
-1.80 IU/mL
Standard Deviation 0.866
|
|
Mean Change From Baseline in HBV-DNA log10
Week 4
|
-0.84 IU/mL
Standard Deviation 0.422
|
-1.49 IU/mL
Standard Deviation 0.652
|
-0.98 IU/mL
Standard Deviation 0.772
|
-2.17 IU/mL
Standard Deviation 0.871
|
|
Mean Change From Baseline in HBV-DNA log10
Week 5
|
NA IU/mL
Standard Deviation NA
Only participants with both a baseline value and a value particular time point were summarized
|
-1.37 IU/mL
Standard Deviation 0.923
|
-1.22 IU/mL
Standard Deviation 0.819
|
NA IU/mL
Standard Deviation NA
Only participants with both a baseline value and a value particular time point were summarized
|
SECONDARY outcome
Timeframe: Day 1, 5, 14, Week 4 and 6Viral sequence data was obtained from the first 10 participants enrolled in Study but on analysis of the data, numerous low frequency deviations from the HBV consensus sequences were observed in the 454 SLX sequence data which were not replicated in data obtained from routine Sanger sequencing. These sequence deviations did not correspond to a temporal pattern consistent with selection of mutations following HBV treatment. Moreover, they could not be reliably distinguished from sequencing artifacts. It was also revealed that complete genome coverage was not obtained due to errors in the design of the primer sequences. For these reasons, further sequence analyses were not performed for the remaining treatment population.
Outcome measures
Outcome data not reported
Adverse Events
Tenofovir 300 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a 360 μg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Delayed Treatment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tenofovir 300 mg
n=6 participants at risk
Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg
n=6 participants at risk
Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
PEG-IFN Alfa-2a 360 μg
n=12 participants at risk
Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
|
Delayed Treatment
n=6 participants at risk
Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
83.3%
5/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
75.0%
9/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
50.0%
3/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
General disorders
Fatigue
|
33.3%
2/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
33.3%
2/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
33.3%
4/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
33.3%
2/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
General disorders
Influenza like illness
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
General disorders
Pain
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
General disorders
Chills
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
2/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
General disorders
Feeling cold
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
General disorders
Injection site rash
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
General disorders
Thirst
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
General disorders
Xerosis
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
83.3%
5/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
50.0%
6/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
66.7%
4/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
25.0%
3/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
41.7%
5/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
33.3%
2/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
33.3%
2/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
2/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
33.3%
2/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
25.0%
3/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
33.3%
2/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
25.0%
3/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Cardiac disorders
Wolff-parkinson-white syndrome
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
8.3%
1/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
16.7%
1/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/12 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
0.00%
0/6 • Up to Week 6
All participants who received at least one dose of the study medication were included in safety analysis.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Email: [email protected]
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