Trial Outcomes & Findings for A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency (NCT NCT04566692)
NCT ID: NCT04566692
Last Updated: 2023-09-29
Results Overview
Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 7 days for participants on weekly IGSC 20% dosing. The data is reported for participants who received weekly dosing.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
Predose and post dose at multiple time points after end of infusion up to Week 15
Results posted on
2023-09-29
Participant Flow
Participants with primary immunodeficiency were enrolled at 15 investigative centers in the United States from 24 November 2020 to 25 July 2022.
Participant milestones
| Measure |
IGSC 20%: Treatment-experienced Cohort
Participants first received 16 weekly doses of IGSC 20% using a subcutaneous (SC) infusion pump from Week 0 to Week 15. Participants entering study on intravenous immune globulin (IVIG), IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on subcutaneous immunoglobulin (SCIG) received the same milligram/kilogram (mg/kg) equivalent weekly dose as given prior to study entry, without using a dose adjustment factor (DAF). Participants then received 9 biweekly doses of IGSC 20 % (i.e, IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
6
|
|
Overall Study
Safety Population
|
27
|
6
|
|
Overall Study
Efficacy Evaluable Population
|
27
|
6
|
|
Overall Study
IgG Population
|
27
|
6
|
|
Overall Study
Pharmacokinetic (PK) Population
|
25
|
0
|
|
Overall Study
COMPLETED
|
24
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
IGSC 20%: Treatment-experienced Cohort
Participants first received 16 weekly doses of IGSC 20% using a subcutaneous (SC) infusion pump from Week 0 to Week 15. Participants entering study on intravenous immune globulin (IVIG), IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on subcutaneous immunoglobulin (SCIG) received the same milligram/kilogram (mg/kg) equivalent weekly dose as given prior to study entry, without using a dose adjustment factor (DAF). Participants then received 9 biweekly doses of IGSC 20 % (i.e, IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
Baseline characteristics by cohort
| Measure |
IGSC 20%: Treatment-experienced Cohort
n=27 Participants
Participants first received 16 weekly doses of IGSC 20% using a SC infusion pump from Week 0 to Week 15. Participants entering study on IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF. Participants then received 9 biweekly doses of IGSC 20 % (i.e, IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
n=6 Participants
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 12.06 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 8.25 • n=7 Participants
|
52.5 years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose and post dose at multiple time points after end of infusion up to Week 15Population: PK population included all the participants who had sufficient PK concentration data to have at least one of the PK parameters AUC (0-7 days), Cmax, or Tmax. Overall number analyzed is the number of participants with data available for analysis.
Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 7 days for participants on weekly IGSC 20% dosing. The data is reported for participants who received weekly dosing.
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=23 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-experienced Cohort: AUC of IGSC 20% Administered Weekly Assessed as: Steady-State AUC of Total IgG Over a Regular Dosing Interval (τ)
|
167045.65 hours*milligrams per deciliter (h*mg/dL)
Geometric Coefficient of Variation 20.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and post dose at multiple timepoints after end of infusion up to Week 32Population: PK population included all the participants who had sufficient PK concentration data to have at least one of the PK parameters AUC (0-7 days), Cmax, or Tmax.
Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 14 days for participants on a biweekly IGSC 20% dosing. AUC (0-14 days) for the biweekly dosing were divided by 2 for comparison with AUC(0-7 days) for the weekly dosing prior to the statistical comparison. The data is reported for participants who received bi-weekly dosing.
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=23 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-experienced Cohort: AUC of IGSC 20% Administered Biweekly Assessed as Steady-State AUC of Total IgG Over a Biweekly Dosing Interval
AUC (0-7 days)
|
170926.08 h*mg/dL
Geometric Coefficient of Variation 21.1
|
—
|
—
|
|
Treatment-experienced Cohort: AUC of IGSC 20% Administered Biweekly Assessed as Steady-State AUC of Total IgG Over a Biweekly Dosing Interval
AUC (0-14 days)
|
341852.17 h*mg/dL
Geometric Coefficient of Variation 21.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and post dose at multiple timepoints after end of infusion up to Week 32Population: PK population included all the participants who had sufficient PK concentration data to have at least one of the PK parameters AUC (0-7 days), Cmax, or Tmax.
The observed maximum total IgG concentration following drug infusion obtained directly from the experimental data without interpolation. The data is reported for participants who received weekly and bi-weekly dosing
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=25 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
n=23 Participants
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-experienced Cohort: Cmax of Total IgG at Steady State Following IGSC 20% Weekly and Biweekly Administration
|
1054.34 milligrams per deciliter (mg/dL)
Geometric Coefficient of Variation 20.6
|
1127.09 milligrams per deciliter (mg/dL)
Geometric Coefficient of Variation 21.4
|
—
|
SECONDARY outcome
Timeframe: Predose and post dose at multiple timepoints after end of infusion up to Week 32Population: PK population included all the participants who had sufficient PK concentration data to have at least one of the PK parameters AUC (0-7 days), Cmax, or Tmax.
The data is reported for participants who received weekly and bi-weekly dosing
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=25 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
n=23 Participants
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-experienced Cohort: Tmax of Total IgG at Steady State Given IGSC 20% Weekly and Biweekly
|
93.650 hours
Interval 0.0 to 123.03
|
96.233 hours
Interval 71.12 to 264.73
|
—
|
SECONDARY outcome
Timeframe: Predose and post dose at multiple timepoints after end of infusion up to Week 32Population: IgG population included all participants who received at least 1 dose of IGSC 20%.
Mean Trough was calculated as the average of the trough concentrations at Weeks 12, 14 Pre-infusion, and 16 for the Weekly Period; and at Weeks 28, 30 Pre-infusion, and 32 for the Biweekly Period. Mean Trough for a given period was not calculated if at least one trough measure was missing. The data is reported for participants who received weekly and bi-weekly dosing.
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=27 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
n=25 Participants
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-experienced Cohort: Steady-State Mean Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
|
978.29 mg/dL
Geometric Coefficient of Variation 18.3
|
960.53 mg/dL
Geometric Coefficient of Variation 20.0
|
—
|
SECONDARY outcome
Timeframe: Screening, IgG Trough 2, Weeks 0, 2, 4, 8, 12, 14 (pre-infusion), 15, 16, 20, 24, 28, 30 (pre-infusion) and 32Population: IgG population included all participants who received at least 1 dose of IGSC 20%. Number analyzed is the number of participants with data available for analysis at specified timepoint.
IgG Trough 2 = For treatment-experienced participants entering the study on IVIG or Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA), a second IgG trough level was obtained after screening; this was summarized in the visit designated as IgG Trough 2. Week 0 = Participants entering IVIG or HYQVIA, the first IGSC 20% dose was approximately 1 week post last IVIG/HYQVIA dose and so IgG at Week 0 for these participants represented a pre-dose value. For participants entering on all other forms of SCIG, the Week 0 value is true trough.
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=27 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Screening
|
954.7 mg/dL
Geometric Coefficient of Variation 24.4
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
IgG Trough 2
|
825.7 mg/dL
Geometric Coefficient of Variation 21.5
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 0
|
1071.8 mg/dL
Geometric Coefficient of Variation 24.1
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 4
|
1069.9 mg/dL
Geometric Coefficient of Variation 19.6
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 8
|
1052.7 mg/dL
Geometric Coefficient of Variation 17.9
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 12
|
1012.0 mg/dL
Geometric Coefficient of Variation 18.7
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 14
|
936.3 mg/dL
Geometric Coefficient of Variation 19.2
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 15
|
945.0 mg/dL
Geometric Coefficient of Variation 19.4
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 16
|
1002.1 mg/dL
Geometric Coefficient of Variation 18.0
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 20
|
952.0 mg/dL
Geometric Coefficient of Variation 19.9
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 24
|
985.6 mg/dL
Geometric Coefficient of Variation 19.8
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 28
|
978.8 mg/dL
Geometric Coefficient of Variation 22.4
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 30
|
933.8 mg/dL
Geometric Coefficient of Variation 20.4
|
—
|
—
|
|
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Week 32 (End of Treatment)
|
966.6 mg/dL
Geometric Coefficient of Variation 19.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening, Weeks 0, 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28 and 32Population: IgG population included all participants who received at least 1 dose of IGSC 20%. Number analyzed is the number of participants with data available for analysis at specified timepoint.
Week 0 = Participants entering IVIG or HYQVIA, the first IGSC 20% dose was approximately 1 week post last IVIG/HYQVIA dose and so IgG at Week 0 for these participants represented a pre-dose value. For participants entering on all other forms of SCIG, the Week 0 value is true trough.
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=6 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Screening
|
201.2 mg/dL
Geometric Coefficient of Variation 99.9
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 0
|
183.3 mg/dL
Geometric Coefficient of Variation 96.7
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 1
|
957.5 mg/dL
Geometric Coefficient of Variation 29.1
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 2
|
856.5 mg/dL
Geometric Coefficient of Variation 33.1
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 4
|
875.3 mg/dL
Geometric Coefficient of Variation 25.7
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 6
|
843.5 mg/dL
Geometric Coefficient of Variation 22.2
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 8
|
879.1 mg/dL
Geometric Coefficient of Variation 24.0
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 10
|
902.4 mg/dL
Geometric Coefficient of Variation 20.8
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 12
|
946.2 mg/dL
Geometric Coefficient of Variation 18.7
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 16
|
953.9 mg/dL
Geometric Coefficient of Variation 16.2
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 20
|
933.7 mg/dL
Geometric Coefficient of Variation 21.3
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 24
|
938.6 mg/dL
Geometric Coefficient of Variation 12.1
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 28
|
955.5 mg/dL
Geometric Coefficient of Variation 15.1
|
—
|
—
|
|
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 32 (End of Treatment)
|
930.6 mg/dL
Geometric Coefficient of Variation 19.5
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening up to final follow up visit at Week 33Population: Efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=27 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
n=6 Participants
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-experienced and Treatment-naïve Cohorts: Number of Participants With Serious Bacterial Infection (SBI)
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From screening up to final follow up visit at Week 33Population: Efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.
Rate of events per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. All infections of any kind included serious/nonserious including acute sinusitis, exacerbation of chronic sinusitis, acute otitis media, pneumonia, acute bronchitis, infectious diarrhea etc.) as determined by the investigator. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=27 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
n=25 Participants
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
n=6 Participants
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-experienced and Treatment-naïve Cohorts: Rate of Events Per Participant Per Year With Infections of Any Kind as Determined by the Investigator
|
2.299 rate of events per participant per year
Interval 1.203 to 4.389
|
1.995 rate of events per participant per year
Interval 1.033 to 3.858
|
2.507 rate of events per participant per year
Interval 1.198 to 5.247
|
SECONDARY outcome
Timeframe: From screening up to final follow up visit at Week 33Population: Efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.
Rate of events per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. A validated treatment-emergent infection was documented by positive radiograph, fever (\>38°C oral or \>39°C rectal), culture, or diagnostic testing for microorganisms e.g., bacterial, viral, fungal, or protozoal pathogens (e.g., rapid streptococcal antigen detection test). Treatment-emergent infection was defined as an infection with onset on or after first infusion start date/time. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=27 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
n=25 Participants
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
n=6 Participants
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-experienced and Treatment-naïve Cohorts: Rate of Events Per Participant Per Year With Validated Infections
|
0.511 rate of events per participant per year
Interval 0.21 to 1.244
|
0.587 rate of events per participant per year
Interval 0.213 to 1.615
|
0.279 rate of events per participant per year
Interval 0.054 to 1.427
|
SECONDARY outcome
Timeframe: From screening up to final follow up visit at Week 33Population: Efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.
Rate of days per person per year is calculated as the total number of days divided by the total duration of exposure in years across all participants. Antibiotics included prophylactic and therapeutic. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=27 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
n=25 Participants
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
n=6 Participants
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-experienced and Treatment-naïve Cohorts: Rate of Days Per Participant Per Year That Participants Were on Antibiotics
Prophylactic Antibiotics
|
15.326 rate of days per participant per year
Interval 5.975 to 39.278
|
15.258 rate of days per participant per year
Interval 6.035 to 38.603
|
0.00 rate of days per participant per year
Interval 0.0 to
Upper limit of 95% CI was not evaluable due to insufficient number of participants with events.
|
|
Treatment-experienced and Treatment-naïve Cohorts: Rate of Days Per Participant Per Year That Participants Were on Antibiotics
Therapeutic Antibiotics
|
19.796 rate of days per participant per year
Interval 10.493 to 37.316
|
10.681 rate of days per participant per year
Interval 5.241 to 21.779
|
23.120 rate of days per participant per year
Interval 8.313 to 64.323
|
SECONDARY outcome
Timeframe: From screening up to final follow up visit at Week 33Population: Efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.
Rate of hospitalizations per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. Hospitalization was considered only in cases of hospital admission (including emergency room stay) for equal or more than 24 hours. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
Outcome measures
| Measure |
IGSC 20%: Weekly Dosing
n=27 Participants
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
n=25 Participants
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
n=6 Participants
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Treatment-experienced and Treatment-naïve Cohorts: Rate of Hospitalizations Per Participant Per Year Due to Infection
|
0.128 rate of events per participant per year
Interval 0.048 to 0.34
|
0.117 rate of events per participant per year
Interval 0.043 to 0.323
|
0.000 rate of events per participant per year
Interval 0.0 to
Upper limit of 95% CI was not evaluable due to insufficient number of participants with events.
|
Adverse Events
IGSC 20%: Weekly Dosing
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
IGSC 20%: Bi-weekly Dosing
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
IGSC 20%: Treatment-naïve Cohort
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IGSC 20%: Weekly Dosing
n=27 participants at risk
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
n=25 participants at risk
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
n=6 participants at risk
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Gastrointestinal disorders
Barrett's oesophagus
|
3.7%
1/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
4.0%
1/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
4.0%
1/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
Other adverse events
| Measure |
IGSC 20%: Weekly Dosing
n=27 participants at risk
Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.
|
IGSC 20%: Bi-weekly Dosing
n=25 participants at risk
Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
|
IGSC 20%: Treatment-naïve Cohort
n=6 participants at risk
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
11.1%
3/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.7%
1/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
4.0%
1/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
General disorders
Infusion site reaction
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
General disorders
Infusion site scab
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.00%
0/27 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
0.00%
0/25 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
16.7%
1/6 • From screening up to final follow up visit at Week 33
Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site may publish results from the Study after 12 months of study completion date or after Grifols confirms there will be no joint, multi-center publication, then institution and/or investigator shall have the right, at their discretion, to publish, either in writing or orally, the results of the study performed under the protocol under certain conditions. At Sponsors' request, Site will remove any Confidential Information (other than Study results).
- Publication restrictions are in place
Restriction type: OTHER