Trial Outcomes & Findings for Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) (NCT NCT01199705)
NCT ID: NCT01199705
Last Updated: 2014-12-12
Results Overview
Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24
Results posted on
2014-12-12
Participant Flow
This multicenter study enrolled subjects at nine of the participating study centers in Japan.
Screening took place 3 to 4 weeks prior to or at the first intravenous immunoglobulin (IVIG) infusion in the IVIG period of the study.
Participant milestones
| Measure |
IgPro20
Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
|
|---|---|
|
IVIG Treatment
STARTED
|
25
|
|
IVIG Treatment
COMPLETED
|
25
|
|
IVIG Treatment
NOT COMPLETED
|
0
|
|
SCIG Treatment (Wash-in/Wash-out)
STARTED
|
25
|
|
SCIG Treatment (Wash-in/Wash-out)
COMPLETED
|
24
|
|
SCIG Treatment (Wash-in/Wash-out)
NOT COMPLETED
|
1
|
|
SCIG Treatment (Efficacy)
STARTED
|
24
|
|
SCIG Treatment (Efficacy)
COMPLETED
|
24
|
|
SCIG Treatment (Efficacy)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
IgPro20
Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
|
|---|---|
|
SCIG Treatment (Wash-in/Wash-out)
Transfer of Residence
|
1
|
Baseline Characteristics
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Baseline characteristics by cohort
| Measure |
IgPro20
n=25 Participants
Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
|
|---|---|
|
Age, Continuous
|
20.6 Years
STANDARD_DEVIATION 13.23 • n=5 Participants
|
|
Age, Customized
< 2 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
≥ 2 to < 12 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
≥ 12 to ≤ 16 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
> 16 to < 65 years
|
14 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Primary Immunodeficiency Type
Common Variable Immunodeficiency (CVID)
|
10 Participants
n=5 Participants
|
|
Primary Immunodeficiency Type
X-Linked Agammaglobulinemia (XLA)
|
13 Participants
n=5 Participants
|
|
Primary Immunodeficiency Type
Autosomal Recessive Agammaglobulinemia (ARAG)
|
1 Participants
n=5 Participants
|
|
Primary Immunodeficiency Type
Hyper-Immunoglobulin M (IgM) Syndrome
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24Population: The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability. The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.
Outcome measures
| Measure |
IgPro20 - Per Protocol Set (PPS)
n=21 Participants
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
|
IgPro20 - Full Analysis Set (FAS)
n=24 Participants
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
|
SCIG Treatment (Efficacy)
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
|
|---|---|---|---|
|
IgG Trough Level
|
1.09 Ratio of Geometric Means
Interval 1.06 to 1.13
|
1.11 Ratio of Geometric Means
Interval 1.08 to 1.15
|
—
|
SECONDARY outcome
Timeframe: Up to 36 weeksNumber of infection episodes (serious and non-serious) presented by study period: * IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20). * SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy. * SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
Outcome measures
| Measure |
IgPro20 - Per Protocol Set (PPS)
n=21 Participants
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
|
IgPro20 - Full Analysis Set (FAS)
n=24 Participants
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
|
SCIG Treatment (Efficacy)
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
|
|---|---|---|---|
|
Number of Infection Episodes (Serious and Non-serious) by Study Period
SCIG IgPro20 Treatment (Efficacy)
|
15 Number of infection episodes
|
18 Number of infection episodes
|
—
|
|
Number of Infection Episodes (Serious and Non-serious) by Study Period
IVIG Treatment
|
19 Number of infection episodes
|
22 Number of infection episodes
|
—
|
|
Number of Infection Episodes (Serious and Non-serious) by Study Period
SCIG IgPro20 Treatment (Wash-in/Wash-out)
|
28 Number of infection episodes
|
32 Number of infection episodes
|
—
|
SECONDARY outcome
Timeframe: Up to 36 weeksPopulation: The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks) * SCIG IgPro20 treatment (efficacy) (12 weeks)
Outcome measures
| Measure |
IgPro20 - Per Protocol Set (PPS)
n=1209 Subject Study Days
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
|
IgPro20 - Full Analysis Set (FAS)
n=1764 Subject Study Days
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
|
SCIG Treatment (Efficacy)
n=1840 Subject Study Days
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
|
|---|---|---|---|
|
Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population
|
5.74 Infections per subject year
|
5.79 Infections per subject year
|
2.98 Infections per subject year
|
SECONDARY outcome
Timeframe: Up to 36 weeksPopulation: The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks) * SCIG IgPro20 treatment (efficacy) (12 weeks)
Outcome measures
| Measure |
IgPro20 - Per Protocol Set (PPS)
n=1396 Subject Study Days
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
|
IgPro20 - Full Analysis Set (FAS)
n=2016 Subject Study Days
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
|
SCIG Treatment (Efficacy)
n=2095 Subject Study Days
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
|
|---|---|---|---|
|
Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population
|
5.75 Infections per subject year
|
5.79 Infections per subject year
|
3.14 Infections per subject year
|
SECONDARY outcome
Timeframe: Up to 36 weeksMedian number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
Outcome measures
| Measure |
IgPro20 - Per Protocol Set (PPS)
n=21 Participants
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
|
IgPro20 - Full Analysis Set (FAS)
n=24 Participants
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
|
SCIG Treatment (Efficacy)
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
|
|---|---|---|---|
|
Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period
IVIG Treatment
|
0 Days
Interval 0.0 to 8.0
|
0 Days
Interval 0.0 to 8.0
|
—
|
|
Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period
SCIG IgPro20 Treatment (Wash-in/Wash-out)
|
0 Days
Interval 0.0 to 9.0
|
0 Days
Interval 0.0 to 9.0
|
—
|
|
Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period
SCIG IgPro20 Treatment (Efficacy)
|
0 Days
Interval 0.0 to 8.0
|
0 Days
Interval 0.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Up to 36 weeksMedian number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
Outcome measures
| Measure |
IgPro20 - Per Protocol Set (PPS)
n=21 Participants
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
|
IgPro20 - Full Analysis Set (FAS)
n=24 Participants
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
|
SCIG Treatment (Efficacy)
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
|
|---|---|---|---|
|
Number of Days of Hospitalization Due to Infections by Study Period
IVIG Treatment
|
0 Days
Interval 0.0 to 1.0
|
0 Days
Interval 0.0 to 1.0
|
—
|
|
Number of Days of Hospitalization Due to Infections by Study Period
SCIG IgPro20 Treatment (Wash-in/Wash-out)
|
0 Days
Interval 0.0 to 0.0
|
0 Days
Interval 0.0 to 0.0
|
—
|
|
Number of Days of Hospitalization Due to Infections by Study Period
SCIG IgPro20 Treatment (Efficacy)
|
0 Days
Interval 0.0 to 3.0
|
0 Days
Interval 0.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Up to 36 weeksMedian number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
Outcome measures
| Measure |
IgPro20 - Per Protocol Set (PPS)
n=21 Participants
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
|
IgPro20 - Full Analysis Set (FAS)
n=24 Participants
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
|
SCIG Treatment (Efficacy)
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
|
|---|---|---|---|
|
Duration of Use of Antibiotics for Infection Prophylaxis and Treatment
IVIG Treatment
|
48.5 Days
Interval 2.0 to 64.0
|
48.0 Days
Interval 2.0 to 64.0
|
—
|
|
Duration of Use of Antibiotics for Infection Prophylaxis and Treatment
SCIG IgPro20 Treatment (Wash-in/Wash-out)
|
49.0 Days
Interval 3.0 to 86.0
|
35.5 Days
Interval 2.0 to 86.0
|
—
|
|
Duration of Use of Antibiotics for Infection Prophylaxis and Treatment
SCIG IgPro20 Treatment (Efficacy)
|
71.0 Days
Interval 6.0 to 85.0
|
71.0 Days
Interval 6.0 to 85.0
|
—
|
SECONDARY outcome
Timeframe: For the duration of the study, up to 36 weeksPopulation: The safety data set (SDS) comprised all subjects treated with the study drug.
The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
Outcome measures
| Measure |
IgPro20 - Per Protocol Set (PPS)
n=75 Infusions
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
|
IgPro20 - Full Analysis Set (FAS)
n=584 Infusions
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
|
SCIG Treatment (Efficacy)
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
|
|---|---|---|---|
|
Rate of All Adverse Events by Relatedness and Seriousness
All AEs
|
0.653 AEs per infusion
|
0.457 AEs per infusion
|
—
|
|
Rate of All Adverse Events by Relatedness and Seriousness
At Least Possibly Related AEs
|
0.027 AEs per infusion
|
0.296 AEs per infusion
|
—
|
|
Rate of All Adverse Events by Relatedness and Seriousness
Serious AEs
|
0 AEs per infusion
|
0.002 AEs per infusion
|
—
|
|
Rate of All Adverse Events by Relatedness and Seriousness
At Least Possibly Related and Serious AEs
|
0 AEs per infusion
|
0 AEs per infusion
|
—
|
SECONDARY outcome
Timeframe: For the duration of the study, up to 36 weeksPopulation: The SDS comprised all subjects treated with the study drug.
In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of: infusion site discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction. Mild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity.
Outcome measures
| Measure |
IgPro20 - Per Protocol Set (PPS)
n=75 Infusions
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
|
IgPro20 - Full Analysis Set (FAS)
n=584 Infusions
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
|
SCIG Treatment (Efficacy)
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
|
|---|---|---|---|
|
Rate of Mild, Moderate, or Severe Local Reactions
Mild Local Reactions
|
0 AEs per infusion
|
0.274 AEs per infusion
|
—
|
|
Rate of Mild, Moderate, or Severe Local Reactions
Moderate Local Reactions
|
0 AEs per infusion
|
0 AEs per infusion
|
—
|
|
Rate of Mild, Moderate, or Severe Local Reactions
Severe Local Reactions
|
0 AEs per infusion
|
0 AEs per infusion
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36 weeksPopulation: The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks) * SCIG IgPro20 treatment (efficacy; 12 weeks)
Outcome measures
| Measure |
IgPro20 - Per Protocol Set (PPS)
n=1209 Subject Study Days
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
|
IgPro20 - Full Analysis Set (FAS)
n=1764 Subject Study Days
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
|
SCIG Treatment (Efficacy)
n=1840 Subject Study Days
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
|
|---|---|---|---|
|
Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population
|
0.00 SBIs per subject year
|
0.00 SBIs per subject year
|
0.00 SBIs per subject year
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36 weeksPopulation: The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks) * SCIG IgPro20 treatment (efficacy; 12 weeks)
Outcome measures
| Measure |
IgPro20 - Per Protocol Set (PPS)
n=1396 Subject Study Days
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
|
IgPro20 - Full Analysis Set (FAS)
n=2016 Subject Study Days
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
|
SCIG Treatment (Efficacy)
n=2095 Subject Study Days
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
|
|---|---|---|---|
|
Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population
|
0.00 SBIs per subject year
|
0.00 SBIs per subject year
|
0.00 SBIs per subject year
|
Adverse Events
IVIG Treatment
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
SCIG Treatment
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IVIG Treatment
n=25 participants at risk
Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).
|
SCIG Treatment
n=25 participants at risk
IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
|
|---|---|---|
|
Infections and infestations
Bacterial infection
|
0.00%
0/25 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
4.0%
1/25 • Number of events 1 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Infections and infestations
Gastroenteritis
|
4.0%
1/25 • Number of events 1 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
0.00%
0/25 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
Other adverse events
| Measure |
IVIG Treatment
n=25 participants at risk
Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).
|
SCIG Treatment
n=25 participants at risk
IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Dental caries
|
4.0%
1/25 • Number of events 1 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
12.0%
3/25 • Number of events 3 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 2 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
0.00%
0/25 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
General disorders
Local reactions
|
0.00%
0/25 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
80.0%
20/25 • Number of events 160 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
12.0%
3/25 • Number of events 3 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Infections and infestations
Conjunctivitis infective
|
4.0%
1/25 • Number of events 1 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
8.0%
2/25 • Number of events 2 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Infections and infestations
Gastroenteritis
|
4.0%
1/25 • Number of events 1 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
12.0%
3/25 • Number of events 5 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Infections and infestations
Influenza
|
16.0%
4/25 • Number of events 4 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
16.0%
4/25 • Number of events 4 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
5/25 • Number of events 8 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
44.0%
11/25 • Number of events 21 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/25 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
12.0%
3/25 • Number of events 3 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.0%
4/25 • Number of events 4 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
20.0%
5/25 • Number of events 8 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/25 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
12.0%
3/25 • Number of events 7 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.0%
2/25 • Number of events 2 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
8.0%
2/25 • Number of events 2 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • Number of events 3 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
4.0%
1/25 • Number of events 1 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
12.0%
3/25 • Number of events 9 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
General disorders
Malaise
|
8.0%
2/25 • Number of events 2 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
4.0%
1/25 • Number of events 2 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
|
Infections and infestations
Pharyngitis
|
12.0%
3/25 • Number of events 3 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
4.0%
1/25 • Number of events 1 • For the duration of the study, up to 36 weeks
The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
|
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