Trial Outcomes & Findings for A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema (NCT NCT01912456)
NCT ID: NCT01912456
Last Updated: 2021-01-29
Results Overview
The time normalized number of HAE attacks as reported by the investigator per subject was calculated as: The total number of HAE attacks per subject and per treatment period / length of stay of subject in treatment period (days), Where length of stay of subject in treatment period was calculated as: Date of last day of subject in treatment period - date of first day of Week 3 of subject in treatment period + 1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
During the treatment phase, up to 28 weeks.
Results posted on
2021-01-29
Participant Flow
Participant milestones
| Measure |
Placebo High/CSL830 (40)
High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks, then a low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (40)/Placebo High
A low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks, then a high-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks.
|
Placebo Low/CSL830 (60)
A low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks then a high-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (60)/Placebo Low
A high-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks, then a low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
22
|
23
|
23
|
22
|
|
Period 1
COMPLETED
|
20
|
22
|
21
|
19
|
|
Period 1
NOT COMPLETED
|
2
|
1
|
2
|
3
|
|
Period 2
STARTED
|
20
|
22
|
21
|
19
|
|
Period 2
COMPLETED
|
20
|
20
|
21
|
18
|
|
Period 2
NOT COMPLETED
|
0
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo High/CSL830 (40)
High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks, then a low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (40)/Placebo High
A low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks, then a high-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks.
|
Placebo Low/CSL830 (60)
A low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks then a high-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (60)/Placebo Low
A high-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks, then a low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks.
|
|---|---|---|---|---|
|
Period 1
Physician Decision
|
0
|
0
|
1
|
0
|
|
Period 1
non-compliance
|
1
|
0
|
0
|
1
|
|
Period 1
Adverse Event
|
1
|
0
|
0
|
1
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
|
Period 2
Lack of Efficacy
|
0
|
2
|
0
|
0
|
|
Period 2
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
Baseline characteristics by cohort
| Measure |
CSL830 (40)/Placebo High
n=45 Participants
|
CSL830 (60)/Placebo Low
n=45 Participants
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 14.41 • n=93 Participants
|
36.8 years
STANDARD_DEVIATION 14.921 • n=4 Participants
|
39.6 years
STANDARD_DEVIATION 14.85 • n=27 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=93 Participants
|
5 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Region of Enrollment
Romania
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=93 Participants
|
26 participants
n=4 Participants
|
54 participants
n=27 Participants
|
|
Region of Enrollment
Czechia
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Region of Enrollment
Israel
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: During the treatment phase, up to 28 weeks.Population: Intention-to-treat (ITT) population consisted of all subjects who provided informed consent / assent and were randomized, regardless of whether they received investigational product.
The time normalized number of HAE attacks as reported by the investigator per subject was calculated as: The total number of HAE attacks per subject and per treatment period / length of stay of subject in treatment period (days), Where length of stay of subject in treatment period was calculated as: Date of last day of subject in treatment period - date of first day of Week 3 of subject in treatment period + 1.
Outcome measures
| Measure |
CSL830 (40)
n=43 Participants
Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (60)
n=43 Participants
High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
Placebo High
n=44 Participants
High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
Placebo Low
n=42 Participants
Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
|---|---|---|---|---|
|
The Time-normalized Number of Hereditary Angioedema Attacks
|
0.04 attacks/day
Standard Error 0.011
|
0.02 attacks/day
Standard Error 0.009
|
0.12 attacks/day
Standard Error 0.011
|
0.13 attacks/day
Standard Error 0.009
|
SECONDARY outcome
Timeframe: During the treatment phase, up to 28 weeks.Population: ITT. Subjects whose time-normalized number of attacks could not be calculated in one or both CSL830 treatment periods were excluded from the analysis. Percentages are based on the number of subjects included in the analysis.
The percentage reduction (%) in the time normalized number of HAE attacks was calculated as: 100 x \[1 - (the time normalized number of HAE attacks when treated with CSL830) / (the time normalized number of HAE attacks when treated with placebo)\]. A subject is classed as a responder if the percentage reduction is \>= 50%.
Outcome measures
| Measure |
CSL830 (40)
n=42 Participants
Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (60)
n=40 Participants
High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
Placebo High
High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
Placebo Low
Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
|---|---|---|---|---|
|
Percentage of Subjects With a ≥ 50% Reduction in the Number of Hereditary Angioedema Attacks by CSL830 Treatment
|
76.2 percentage of participants
Interval 61.5 to 86.5
|
90.0 percentage of participants
Interval 76.9 to 96.0
|
—
|
—
|
SECONDARY outcome
Timeframe: During the treatment phase, up to 28 weeks.Population: ITT
The time-normalized number of uses of rescue medication during treatment with C1-esterase inhibitor or placebo
Outcome measures
| Measure |
CSL830 (40)
n=43 Participants
Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (60)
n=43 Participants
High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
Placebo High
n=44 Participants
High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
Placebo Low
n=42 Participants
Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
|---|---|---|---|---|
|
Time-Normalized Number of Uses of Rescue Medication
|
0.04 rescue medication uses/day
Standard Error 0.042
|
0.01 rescue medication uses/day
Standard Error 0.011
|
0.18 rescue medication uses/day
Standard Error 0.04
|
0.13 rescue medication uses/day
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Within 24 hours of C1-esterase inhibitor or placebo administration.Population: The Safety Population (SP) consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product.
Outcome measures
| Measure |
CSL830 (40)
n=43 Participants
Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (60)
n=43 Participants
High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
Placebo High
n=44 Participants
High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
Placebo Low
n=42 Participants
Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
|---|---|---|---|---|
|
Percentage of Subjects With Adverse Events (AEs) Within 24 Hours of C1-esterase Inhibitor or Placebo Administration
|
58.1 percentage of participants
|
60.5 percentage of participants
|
45.5 percentage of participants
|
54.8 percentage of participants
|
SECONDARY outcome
Timeframe: During the treatment phase, up to 32 weeks.Population: SP
The percentage of subjects experiencing the following during treatment with CSL830 and placebo: unsolicited AEs, serious AEs, suspected adverse drug reactions, increased risk scores for deep vein thrombosis and pulmonary embolism, thromboembolic events, inhibitory anti C1 INH antibodies, or clinically significant abnormalities in laboratory assessments.
Outcome measures
| Measure |
CSL830 (40)
n=43 Participants
Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (60)
n=43 Participants
High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
Placebo High
n=44 Participants
High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
Placebo Low
n=42 Participants
Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
|---|---|---|---|---|
|
Percentage of Subjects With AEs or Other Specified Safety Events.
|
67.4 percentage of participants
|
69.8 percentage of participants
|
61.4 percentage of participants
|
71.4 percentage of participants
|
SECONDARY outcome
Timeframe: During the treatment phase, up to 32 weeks.Population: SP
The percentage of subjects experiencing solicited local AEs (discomfort \[eg, pain, burning\], swelling, bruising, or itching at the investigational product injection site) during treatment with CSL830 and placebo.
Outcome measures
| Measure |
CSL830 (40)
n=43 Participants
Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (60)
n=43 Participants
High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
Placebo High
n=44 Participants
High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
Placebo Low
n=42 Participants
Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
|---|---|---|---|---|
|
Percentage of Subjects Experiencing Solicited AEs (Injection Site Reactions)
|
27.9 percentage of participants
|
34.9 percentage of participants
|
22.7 percentage of participants
|
26.2 percentage of participants
|
SECONDARY outcome
Timeframe: During the treatment phase, up to 32 weeks.Population: SP
The rate/injection of injections of C1-esterase inhibitor or placebo that were followed by solicited local AEs (discomfort \[eg, pain, burning\], swelling, bruising, or itching at the investigational product injection site) during treatment with CSL830 and placebo. Rate/Injection = Number of events/number of injections.
Outcome measures
| Measure |
CSL830 (40)
n=1307 number of injections within treatment
Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (60)
n=1320 number of injections within treatment
High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
Placebo High
n=1290 number of injections within treatment
High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
Placebo Low
n=1164 number of injections within treatment
Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
|---|---|---|---|---|
|
Injections Resulting in Solicited AEs (Injection Site Reactions)
|
0.21 injection site reactions/injection
|
0.08 injection site reactions/injection
|
0.12 injection site reactions/injection
|
0.05 injection site reactions/injection
|
Adverse Events
CSL830 (40)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
CSL830 (60)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo High
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Low
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CSL830 (40)
n=43 participants at risk
Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (60)
n=43 participants at risk
High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
Placebo High
n=44 participants at risk
High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
Placebo Low
n=42 participants at risk
Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Hereditary angioedema
|
0.00%
0/43 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/43 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/44 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
2.4%
1/42 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/43 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/43 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
2.3%
1/44 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/42 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
Nervous system disorders
Syncope
|
0.00%
0/43 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/43 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/44 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
2.4%
1/42 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
Infections and infestations
Urosepsis
|
2.3%
1/43 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/43 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/44 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/42 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
Other adverse events
| Measure |
CSL830 (40)
n=43 participants at risk
Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
CSL830 (60)
n=43 participants at risk
High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.
|
Placebo High
n=44 participants at risk
High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
Placebo Low
n=42 participants at risk
Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
9.3%
4/43 • Number of events 5 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/43 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/44 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
2.4%
1/42 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
General disorders
Injection site erythema
|
16.3%
7/43 • Number of events 86 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
20.9%
9/43 • Number of events 20 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
13.6%
6/44 • Number of events 36 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
16.7%
7/42 • Number of events 28 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
General disorders
Injection site pain
|
16.3%
7/43 • Number of events 90 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
16.3%
7/43 • Number of events 19 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
11.4%
5/44 • Number of events 34 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
9.5%
4/42 • Number of events 9 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
General disorders
Injection site bruising
|
4.7%
2/43 • Number of events 5 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
9.3%
4/43 • Number of events 5 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
4.5%
2/44 • Number of events 2 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
7.1%
3/42 • Number of events 5 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
General disorders
Injection site swelling
|
2.3%
1/43 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
9.3%
4/43 • Number of events 39 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
4.5%
2/44 • Number of events 6 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
4.8%
2/42 • Number of events 18 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
General disorders
Injection site induration
|
7.0%
3/43 • Number of events 8 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
9.3%
4/43 • Number of events 6 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
2.3%
1/44 • Number of events 2 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
2.4%
1/42 • Number of events 2 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
General disorders
Fatigue
|
2.3%
1/43 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
2.3%
1/43 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
6.8%
3/44 • Number of events 3 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
7.1%
3/42 • Number of events 3 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
General disorders
Injection site edema
|
11.6%
5/43 • Number of events 60 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/43 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
4.5%
2/44 • Number of events 62 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
2.4%
1/42 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
General disorders
Injection site haemorrhage
|
7.0%
3/43 • Number of events 8 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
2.3%
1/43 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
9.1%
4/44 • Number of events 4 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
0.00%
0/42 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/43 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
2.3%
1/43 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
6.8%
3/44 • Number of events 4 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
4.8%
2/42 • Number of events 4 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
1/43 • Number of events 1 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
18.6%
8/43 • Number of events 9 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
6.8%
3/44 • Number of events 3 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
7.1%
3/42 • Number of events 3 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
3/43 • Number of events 3 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
7.0%
3/43 • Number of events 3 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
6.8%
3/44 • Number of events 3 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
7.1%
3/42 • Number of events 3 • During the treatment phase, up to 32 weeks.
The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER