Trial Outcomes & Findings for A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID) (NCT NCT05150340)

Last Updated: 2024-11-25

Results Overview

The data was reported at Week 7, 11, 15, 19, 23, 27, and 31 for 4-Week interval and at Week 4, 7, 10, 13, 16, 19, 22, 25 and 28 for 3-Week interval.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

16 participants

Primary outcome timeframe

Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval

Results posted on

2024-11-25

Participant Flow

Participants with a confirmed diagnosis of primary immunodeficiency diseases (PID) took part in the study at 12 investigative sites in Japan from 24 January 2022 to 28 August 2023.

Participants with PID, who had been receiving a consistent dose of intravenous immunoglobulin (IVIG), conventional subcutaneous immunoglobulin (cSCIG) or TAK-664 (immune globulin subcutaneous \[human\], 20% solution \[20%SCIG\]) for at least 3 months prior to screening were enrolled in the study to receive TAK-771.

Participant milestones

Participant milestones
Measure	Epoch 1: TAK-771 Ramp up Period TAK-771 included IGI 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of 10% IGI was increased from 1/3 of full dose to full dose in 3 weeks for participants who received TAK-771 once every 3 weeks, or from 1/4 of full dose to full dose in 6 weeks for participants who received TAK-771 once every 4 weeks.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 1 STARTED	16	0
Epoch 1 Pharmacokinetic Analysis Set 1	16	0
Epoch 1 Pharmacokinetic Analysis Set 2	0	0
Epoch 1 COMPLETED	16	0
Epoch 1 NOT COMPLETED	0	0
Epoch 2 STARTED	0	16
Epoch 2 Pharmacokinetic Analysis Set 1	0	16
Epoch 2 Pharmacokinetic Analysis Set 2	0	4
Epoch 2 COMPLETED	0	16
Epoch 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epoch 1: TAK-771 n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of 10% IGI was increased from 1/3 of full dose to full dose in 3 weeks for participants who received TAK-771 once every 3 weeks, or from 1/4 of full dose to full dose in 6 weeks for participants who received TAK-771 once every 4 weeks.
Age, Continuous	25.2 Years STANDARD_DEVIATION 16.86 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Japan	16 Participants n=5 Participants
Height at Baseline	149.26 Centimeters (cm) STANDARD_DEVIATION 25.892 • n=5 Participants
Weight at Baseline	44.33 Kilograms (kg) STANDARD_DEVIATION 16.509 • n=5 Participants
Body Mass Index (BMI)	19.05 kilograms per meter square (kg/m^2) STANDARD_DEVIATION 2.747 • n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval

Population: PK analysis set: all enrolled participants who received investigational drug once, have had at least 1 evaluable serum IgG concentration, and no major protocol deviations or events that would affect serum IgG concentration analysis results. PK set 1: analysis of total serum IgG trough levels for total serum levels of IgG and IgG subclasses. Overall number analyzed: number of participants available for analysis. Number analyzed: participants with data available for analysis at given timepoint.

The data was reported at Week 7, 11, 15, 19, 23, 27, and 31 for 4-Week interval and at Week 4, 7, 10, 13, 16, 19, 22, 25 and 28 for 3-Week interval.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 7, 4-Week Interval	9.372 grams/Liter (g/L) Geometric Coefficient of Variation 10.3	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 11, 4-Week Interval	8.741 grams/Liter (g/L) Geometric Coefficient of Variation 13.7	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 15, 4-Week Interval	8.929 grams/Liter (g/L) Geometric Coefficient of Variation 13.0	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 19, 4-Week Interval	9.150 grams/Liter (g/L) Geometric Coefficient of Variation 15.5	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 23, 4-Week Interval	8.944 grams/Liter (g/L) Geometric Coefficient of Variation 20.9	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 27, 4-Week Interval	9.006 grams/Liter (g/L) Geometric Coefficient of Variation 18.4	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 31, 4-Week Interval	9.159 grams/Liter (g/L) Geometric Coefficient of Variation 20.8	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 4, 3-Week Interval	13.51 grams/Liter (g/L) Geometric Coefficient of Variation 29.7	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 7, 3-Week Interval	13.15 grams/Liter (g/L) Geometric Coefficient of Variation 35.7	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 10, 3-Week Interval	12.54 grams/Liter (g/L) Geometric Coefficient of Variation 43.2	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 16, 3-Week Interval	13.50 grams/Liter (g/L) Geometric Coefficient of Variation 39.7	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 19, 3-Week Interval	12.76 grams/Liter (g/L) Geometric Coefficient of Variation 46.9	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 22, 3-Week Interval	12.79 grams/Liter (g/L) Geometric Coefficient of Variation 40.1	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 25, 3-Week Interval	12.95 grams/Liter (g/L) Geometric Coefficient of Variation 57.6	—
Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 Week 28, 3-Week Interval	12.70 grams/Liter (g/L) Geometric Coefficient of Variation 43.0	—

SECONDARY outcome

Timeframe: Pre-infusion at Week 27 for participants with 4-Week or Week 25 with 3-Week dosing interval and post infusion at multiple time points up to Week 31 for participants with 4-Week dosing interval and up to Week 28 with 3-Week dosing interval.

Population: Pharmacokinetic analysis set included all enrolled participants who received investigational drug at least once, have had at least 1 evaluable serum IgG concentration, and no major protocol deviations or events that would affect the serum IgG concentration analysis results. Pharmacokinetic analysis set 2 included the analysis of PK parameters for total serum levels of IgG, for baseline-corrected total serum levels of IgG, and for IgG subclasses in Epoch 2.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=4 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Maximum Concentration (Cmax) of Total Serum Levels of IgG and IgG Subclasses Total IgG	12.72 g/L Geometric Coefficient of Variation 23.4	—
Epoch 2: Maximum Concentration (Cmax) of Total Serum Levels of IgG and IgG Subclasses IgG Subclass (IgG 1)	7.694 g/L Geometric Coefficient of Variation 16.7	—
Epoch 2: Maximum Concentration (Cmax) of Total Serum Levels of IgG and IgG Subclasses IgG Subclass (IgG 2)	4.140 g/L Geometric Coefficient of Variation 23.0	—
Epoch 2: Maximum Concentration (Cmax) of Total Serum Levels of IgG and IgG Subclasses IgG Subclass (IgG 3)	0.2396 g/L Geometric Coefficient of Variation 46.7	—
Epoch 2: Maximum Concentration (Cmax) of Total Serum Levels of IgG and IgG Subclasses IgG Subclass (IgG 4)	0.3200 g/L Geometric Coefficient of Variation 36.3	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=4 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Time to Maximum Concentration (Tmax) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Total IgG	6.94 days Interval 2.94 to 8.85	—
Epoch 2: Time to Maximum Concentration (Tmax) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 1)	3.92 days Interval 2.94 to 8.83	—
Epoch 2: Time to Maximum Concentration (Tmax) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 2)	3.92 days Interval 2.94 to 8.83	—
Epoch 2: Time to Maximum Concentration (Tmax) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 3)	2.99 days Interval 2.8 to 8.83	—
Epoch 2: Time to Maximum Concentration (Tmax) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 4)	3.88 days Interval 2.8 to 5.04	—

SECONDARY outcome

Population: PK analysis set: all enrolled participants who received investigational drug at least once, have had at least 1 evaluable serum IgG concentration, and no major protocol deviations or events that would affect the serum IgG concentration analysis results. PK analysis set 2: analysis of PK parameters for total serum levels of IgG, for baseline-corrected total serum levels of IgG, and for IgG subclasses in Epoch 2. Number of participants analyzed are number of participants available for analysis.

AUC is expressed as grams\*day per liter/grams per kilograms \[(g\*day/L)/(g/kg)\].

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=4 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Total IgG, AUCtau/Dose	767.9 (g*day/L)/(g/kg) Geometric Coefficient of Variation 40.0	—
Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Total IgG, AUClast/Dose	625.6 (g*day/L)/(g/kg) Geometric Coefficient of Variation 55.2	—
Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 1), AUCtau/Dose	432.4 (g*day/L)/(g/kg) Geometric Coefficient of Variation 36.2	—
Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 1), AUClast/Dose	370.7 (g*day/L)/(g/kg) Geometric Coefficient of Variation 53.0	—
Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 2), AUCtau/Dose	230.4 (g*day/L)/(g/kg) Geometric Coefficient of Variation 25.2	—
Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 2), AUClast/Dose	197.4 (g*day/L)/(g/kg) Geometric Coefficient of Variation 40.5	—
Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 3), AUCtau/Dose	7.916 (g*day/L)/(g/kg) Geometric Coefficient of Variation 165.6	—
Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 3), AUClast/Dose	5.449 (g*day/L)/(g/kg) Geometric Coefficient of Variation 227.2	—
Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 4), AUCtau/Dose	15.65 (g*day/L)/(g/kg) Geometric Coefficient of Variation 37.1	—
Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 4), AUClast/Dose	12.08 (g*day/L)/(g/kg) Geometric Coefficient of Variation 53.4	—

SECONDARY outcome

Timeframe: At multiple time points post-infusion from Week 7 for participants with 4-Week or Week 4 with 3-Week dosing interval up to Week 31 for participants with 4-Week dosing interval and up to Week 28 with 3-Week dosing interval

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=4 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Half-life of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Total IgG	NA day Data was not calculated due to \<3 contributes based on the analysis plan for this outcome measure.	—
Epoch 2: Half-life of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 1)	59.7 day Interval 40.4 to 77.9	—
Epoch 2: Half-life of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 2)	49.6 day Interval 40.8 to 71.4	—
Epoch 2: Half-life of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 3)	NA day Data was not calculated due to \<3 contributes based on the analysis plan for this outcome measure.	—
Epoch 2: Half-life of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 4)	35.9 day Interval 35.8 to 46.3	—

SECONDARY outcome

Population: PK analysis set: all enrolled participants who received investigational drug at least once, have had at least 1 evaluable serum IgG concentration, and no major protocol deviations or events that would affect the serum IgG concentration analysis results. PK analysis set 2: the analysis of PK parameters for total serum levels of IgG, for baseline-corrected total serum levels of IgG, and for IgG subclasses in Epoch 2. Number of participants analyzed is number of participants available for analysis.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=4 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Apparent Total Clearance (CL/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Total IgG	76.84 milliliters per day (mL/day) Geometric Coefficient of Variation 29.4	—
Epoch 2: Apparent Total Clearance (CL/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 1)	117.0 milliliters per day (mL/day) Geometric Coefficient of Variation 37.9	—
Epoch 2: Apparent Total Clearance (CL/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 2)	219.6 milliliters per day (mL/day) Geometric Coefficient of Variation 36.8	—
Epoch 2: Apparent Total Clearance (CL/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 3)	6392 milliliters per day (mL/day) Geometric Coefficient of Variation 176.6	—
Epoch 2: Apparent Total Clearance (CL/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 4)	3234 milliliters per day (mL/day) Geometric Coefficient of Variation 58.0	—

SECONDARY outcome

Population: PK analysis set included all enrolled participants who received investigational drug at least once, have had at least 1 evaluable serum IgG concentration, and no major protocol deviations or events that would affect the serum IgG concentration analysis results. PK analysis set 2=analysis of PK parameters for total serum levels of IgG, for baseline-corrected total serum levels of IgG, and for IgG subclasses in Epoch 2. Number participants analyzed: number of participants available for analysis.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=4 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Apparent Volume of Distribution (Vz/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Total IgG	NA mL Geometric Coefficient of Variation NA Data was not estimable as the concentrations for all participants were below the limit of quantitation.	—
Epoch 2: Apparent Volume of Distribution (Vz/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 1)	8193 mL Geometric Coefficient of Variation 54.9	—
Epoch 2: Apparent Volume of Distribution (Vz/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 2)	14650 mL Geometric Coefficient of Variation 57.0	—
Epoch 2: Apparent Volume of Distribution (Vz/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 3)	NA mL Geometric Coefficient of Variation NA Data was not estimable as the concentrations for all participants were below the limit of quantitation.	—
Epoch 2: Apparent Volume of Distribution (Vz/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 4)	165900 mL Geometric Coefficient of Variation 88.3	—

SECONDARY outcome

Population: PK analysis set: all enrolled participants who received investigational drug at least once, have had at least 1 evaluable serum IgG concentration, and no major protocol deviations or events that would affect serum IgG concentration analysis results. PK analysis set 2: analysis of PK parameters for total serum levels of IgG, for baseline-corrected total serum levels of IgG, and for IgG subclasses in Epoch 2. Number of participants analyzed: number of participants available for analysis.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=4 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Minimum Concentration (Cmin) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Total IgG	9.347 g/L Geometric Coefficient of Variation 17.9	—
Epoch 2: Minimum Concentration (Cmin) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 1)	5.479 g/L Geometric Coefficient of Variation 10.7	—
Epoch 2: Minimum Concentration (Cmin) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 2)	2.941 g/L Geometric Coefficient of Variation 19.8	—
Epoch 2: Minimum Concentration (Cmin) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 3)	NA g/L Geometric Coefficient of Variation NA Data was not estimable as the concentrations for participant were below the limit of quantitation.	—
Epoch 2: Minimum Concentration (Cmin) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) IgG Subclass (IgG 4)	0.2255 g/L Geometric Coefficient of Variation 8.4	—

SECONDARY outcome

Timeframe: 4-Week dosing interval (Week 7, Week 11, Week 15, Week 19, Week 23, Week 27, and Week 31); 3-Week dosing interval (Week 4, week 7, Week 10, Week 16, Week 19, Week 22, Week 25, and Week 28)

Population: PK analysis set: all enrolled participants who received investigational drug at least once, have had at least 1 evaluable serum IgG concentration, and no major protocol deviations or events that would affect the serum IgG concentration analysis results. PK analysis set 2: analysis of PK parameters for total serum levels of IgG, for baseline-corrected total serum levels of IgG, and for IgG subclasses in Epoch 2. Number analyzed: participants with data available for analysis at given time point.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 15, 4-Week Interval	2.912 g/L Geometric Coefficient of Variation 13.5	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 19, 4-Week Interval	3.043 g/L Geometric Coefficient of Variation 16.5	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 23, 4-Week Interval	2.976 g/L Geometric Coefficient of Variation 16.7	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 27, 4-Week Interval	3.078 g/L Geometric Coefficient of Variation 15.5	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 25, 3-Week Interval	8.573 g/L Geometric Coefficient of Variation 82.9	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 28, 3-Week Interval	8.845 g/L Geometric Coefficient of Variation 68.3	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 4, 3-Week Interval	1.936 g/L Geometric Coefficient of Variation 105.6	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 7, 3-Week Interval	1.859 g/L Geometric Coefficient of Variation 89.7	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 10, 3-Week Interval	1.852 g/L Geometric Coefficient of Variation 83.0	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 7, 4-Week Interval	5.478 g/L Geometric Coefficient of Variation 12.1	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 11, 4-Week Interval	5.106 g/L Geometric Coefficient of Variation 15.6	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 15, 4-Week Interval	4.987 g/L Geometric Coefficient of Variation 11.9	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 19, 4-Week Interval	5.063 g/L Geometric Coefficient of Variation 10.1	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 23, 4-Week Interval	4.873 g/L Geometric Coefficient of Variation 10.8	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 27, 4-Week Interval	5.066 g/L Geometric Coefficient of Variation 16.6	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 31, 4-Week Interval	5.104 g/L Geometric Coefficient of Variation 14.0	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 7, 4-Week Interval	3.147 g/L Geometric Coefficient of Variation 20.1	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 11, 4-Week Interval	2.931 g/L Geometric Coefficient of Variation 15.0	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 31, 4-Week Interval	3.091 g/L Geometric Coefficient of Variation 18.3	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 3, Week 7, 4-Week Interval	0.1380 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 3, Week 11, 4-Week Interval	0.1780 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 3, Week 15, 4-Week Interval	0.1390 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 3, Week 27, 4-Week Interval	0.2280 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 7, 4-Week Interval	0.1933 g/L Geometric Coefficient of Variation 15.9	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 11, 4-Week Interval	0.1965 g/L Geometric Coefficient of Variation 22.7	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 15, 4-Week Interval	0.2020 g/L Geometric Coefficient of Variation 16.8	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 19, 4-Week Interval	0.2057 g/L Geometric Coefficient of Variation 16.1	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 23, 4-Week Interval	0.2054 g/L Geometric Coefficient of Variation 14.6	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 27, 4-Week Interval	0.2228 g/L Geometric Coefficient of Variation 24.6	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 31, 4-Week Interval	0.2265 g/L Geometric Coefficient of Variation 25.6	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 4, 3-Week Interval	9.699 g/L Geometric Coefficient of Variation 55.6	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 7, 3-Week Interval	8.906 g/L Geometric Coefficient of Variation 67.0	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 10, 3-Week Interval	8.661 g/L Geometric Coefficient of Variation 66.7	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 16, 3-Week Interval	8.860 g/L Geometric Coefficient of Variation 68.0	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 19, 3-Week Interval	8.687 g/L Geometric Coefficient of Variation 68.9	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 1, Week 22, 3-Week Interval	8.641 g/L Geometric Coefficient of Variation 64.3	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 16, 3-Week Interval	1.964 g/L Geometric Coefficient of Variation 82.5	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 19, 3-Week Interval	1.944 g/L Geometric Coefficient of Variation 82.1	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 22, 3-Week Interval	1.957 g/L Geometric Coefficient of Variation 89.1	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 25, 3-Week Interval	1.910 g/L Geometric Coefficient of Variation 73.5	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 2, Week 28, 3-Week Interval	1.948 g/L Geometric Coefficient of Variation 88.1	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 4, 3-Week Interval	0.1680 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 7, 3-Week Interval	0.1680 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 10, 3-Week Interval	0.2010 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 16, 3-Week Interval	0.2280 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 19, 3-Week Interval	0.2120 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 22, 3-Week Interval	0.2230 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 25, 3-Week Interval	0.2060 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—
Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 IgG 4, Week 28, 3-Week Interval	0.2390 g/L Geometric Coefficient of Variation NA Geometric Coefficient of variation could not be determined for single participant.	—

SECONDARY outcome

Timeframe: From Week 1, up to end of trial (EOS: Week 31 for participants with 4-Week dosing interval or Week 28 for participants with 3-Week dosing interval)

Population: PK Analysis Set included all enrolled participants who received investigational drug at least once, have had at least 1 evaluable serum IgG concentration, and no major protocol deviations or events that would affect the serum IgG concentration analysis results. PK Analysis Set included the analysis of total serum IgG trough levels for total serum levels of IgG and IgG subclasses. Number analyzed are number of participants with data available for analysis at given timepoint.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 1 and 2: Trough Levels of Anti-Clostridium Tetani Toxoid Antibody After Administration of TAK-771 Week 1	1.334 IU/mL Geometric Coefficient of Variation 84.4	—
Epoch 1 and 2: Trough Levels of Anti-Clostridium Tetani Toxoid Antibody After Administration of TAK-771 End of Trial (EOS)	1.578 IU/mL Geometric Coefficient of Variation 68.4	—

SECONDARY outcome

Timeframe: From Week 1, up to end of trial (EOS: Week 31 for participants with 4-Week dosing interval or Week 28 for participants with 3-Week dosing interval)

Population: Pharmacokinetic Analysis Set included all enrolled participants who received investigational drug at least once, have had at least 1 evaluable serum IgG concentration, and no major protocol deviations or events that would affect serum IgG concentration analysis results. Pharmacokinetic Analysis Set included analysis of total serum IgG trough levels for total serum levels of IgG and IgG subclasses. Number analyzed are number of participants with data available for analysis at given timepoint.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 1 and 2: Trough Levels of Anti-HBV Antibody After Administration of TAK-771 Week 1	278.38 mIU/mL Geometric Coefficient of Variation 125.0	—
Epoch 1 and 2: Trough Levels of Anti-HBV Antibody After Administration of TAK-771 End of Trial (EOS)	383.37 mIU/mL Geometric Coefficient of Variation 57.7	—

SECONDARY outcome

Timeframe: From Week 1, up to end of trial (EOS: Week 31 for participants with 4-Week dosing interval or Week 28 for participants with 3-Week dosing interval).

Population: PK Analysis Set included all enrolled participants who received investigational drug at least once, have had at least 1 evaluable serum IgG concentration, and no major protocol deviations or events that would affect the serum IgG concentration analysis results. PK Analysis Set included analysis of total serum IgG trough levels for total serum levels of IgG and IgG subclasses. Number analyzed are number of participants with data available for analysis at given timepoint.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 1 and 2: Trough Levels of Anti-HIB Antibody After Administration of TAK-771 Week 1	1.958 ug/mL Geometric Coefficient of Variation 45.7	—
Epoch 1 and 2: Trough Levels of Anti-HIB Antibody After Administration of TAK-771 End of Trial (EOS)	1.519 ug/mL Geometric Coefficient of Variation 46.8	—

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Population: Safety analysis set included all enrolled participants who received investigational drug at least once. Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.

TEAEs are defined as Adverse events (AEs) with onset after date-time of first dose of Investigational product (IP), or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	81.3 percentage of participants	93.8 percentage of participants

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Percentage of Participants With TAK-771-Related and TAK-771-Non-Related TEAEs TEAE Related	56.3 percentage of participants	68.8 percentage of participants
Percentage of Participants With TAK-771-Related and TAK-771-Non-Related TEAEs TEAE Non-Related	62.5 percentage of participants	81.3 percentage of participants

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

TEAEs are defined as AEs with onset after date-time of first dose of IP, or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. Serious TEAE=any untoward clinical manifestation of signs, symptoms, outcomes (related to IP or not) at any dose: results in death, was life-threatening, requires inpatient/prolongation of hospitalization, resulted in persistent/significant disability/incapacity, congenital abnormality/birth defect, important medical event. AESI=investigator-reported hypersensitivity reactions, events of disordered coagulation as bleeding/hypercoagulable AESI.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Percentage of Participants With Serious and Non-serious TEAEs Serious TEAEs	6.3 percentage of participants	6.3 percentage of participants
Percentage of Participants With Serious and Non-serious TEAEs Non-serious TEAEs	81.3 percentage of participants	93.8 percentage of participants

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Percentage of Participants With Severe TEAEs	0 Percentage of participants	6.3 Percentage of participants

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Percentage of Participants With Local and Systemic TEAEs Local TEAEs	43.8 percentage of participants	43.8 percentage of participants
Percentage of Participants With Local and Systemic TEAEs Systemic TEAEs	75.0 percentage of participants	87.5 percentage of participants

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Percentage of Participants With TEAEs Leading to Premature Discontinuation From Study	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Percentage of Participants With Infusion-associated TEAEs	37.5 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Parameters Recorded as TEAEs	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Percentage of Participants With Clinically Significant Changes in Vital Signs and Body Weight Recorded as TEAEs	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 4-Week Dosing Interval (Week 7, Week 19, and Week 31); 3-Week Dosing Interval (Week 4, Week 16, and Week 28)

Population: Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Percentage of Participants Who Develop Anti-rHuPH20 Binding Antibody Titers of Greater Than or Equal to 1:160	0 percentage of participants	—

SECONDARY outcome

Timeframe: 4-Week Dosing Interval (Week 7, Week 19, and Week 31); 3-Week Dosing Interval (Week 4, Week 16, and Week 28)

Population: Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Percentage of Participants Who Develop Neutralizing Antibodies to rHuPH20	0 percentage of participants	—

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Population: Safety Analysis Set included all enrolled participants who received investigational drug at least once. Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.

Tolerability events is defined as a case that the infusion rate is reduced, or that the infusion is interrupted or stopped, due to a TEAE related to TAK-771 infusion.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Percentage of Participants Who Experienced Tolerability Events Related to the Infusion of TAK-771	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 4 for Participants with 4-Week Dosing Interval or Up to Week 3 for Participants with 3-Week Dosing Interval

Population: Safety Analysis Set included all enrolled participants who received investigational drug at least once.

The number of weeks to reach final dose interval is defined as treatment duration of Epoch 1.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 1: Number of Weeks to Reach Final Dose Interval (3 Weeks or 4 Weeks)	6.00 weeks Interval 3.0 to 6.9	—

SECONDARY outcome

Timeframe: Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval

Population: Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Percentage of Participants Who Achieve a Treatment Interval of 3 or 4 Weeks	100.0 percentage of participants	—

SECONDARY outcome

Timeframe: Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval

Population: Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Epoch 2: Percentage of Participants Who Maintain a Treatment Interval of 3 or 4 Weeks	100.0 percenatge of participants	—

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Population: Full Analysis Set included all enrolled participants who received investigational drug at least once.

The annual rate of validated ASBIs is calculated as the mean number of ASBIs per participant per year.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Annual Rate of Validated Acute Serious Bacterial Infections (ASBIs) Per Participant Per Year	0.00 ASBIs per participant per year Standard Deviation 0.00	—

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Population: Full Analysis Set included all enrolled participants who received investigational drug at least once.

The annual rate of all infections is calculated as the mean number of infections per participant per year.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Annual Rate of All Infections Per Participant Per Year	2.69 infections per participant per year Standard Deviation 3.133	—

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Population: Full Analysis Set included all enrolled participants who received investigational drug at least once.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Healthcare Resource Utilization: Days Not Able To Attend School/Work or To Perform Normal Daily Activities Due to Illness/Infection	0 number of days Interval 0.0 to 26.8	—

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Population: Full Analysis Set included all enrolled participants who received investigational drug at least once.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Healthcare Resource Utilization: Days on Antibiotics	0 number of days Interval 0.0 to 40.2	—

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Population: Full Analysis Set included all enrolled participants who received investigational drug at least once.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Healthcare Resource Utilization: Number of Hospitalizations Due to Illness/Infection Per Year	0.22 hospitalizations per year Standard Deviation 0.591	—

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Population: Full Analysis Set included all enrolled participants who received investigational drug at least once.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Healthcare Resource Utilization: Length of Stay in Days of Hospitalizations Due to Illness/Infection Per Participant Per Year	0 hospitalization days/participant/year Interval 0.0 to 10.5	—

SECONDARY outcome

Timeframe: From Week 1 up to Week 31 for Participants with 4-Week Dosing Interval or up to Week 28 for Participants with 3-Week Dosing Interval

Population: Full Analysis Set included all enrolled participants who received investigational drug at least once.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Healthcare Resource Utilization: Number of Acute (Urgent or Unscheduled) Physician Visits Due to Illness/Infection	1.74 Acute Physician Visits Interval 0.0 to 11.7	—

SECONDARY outcome

Timeframe: From Week 7 up to Week 31 for Participants with 4-Week Dosing Interval or From Week 4 up to Week 28 for Participants with 3-Week Dosing Interval

Population: Epoch 2 Full Analysis Set included all participants who received investigational drug at least once in Epoch 2.

Total number of infusion sites injected in Epoch 2 / Total number of infusions administered in Epoch 2.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Infusion Parameters in Epoch 2: Number of Infusion Sites Per Infusion	1.77 infusion sites per infusion Standard Deviation 0.394	—

SECONDARY outcome

Timeframe: From Week 7 up to Week 31 for Participants with 4-Week Dosing Interval or From Week 4 up to Week 28 for Participants with 3-Week Dosing Interval

Population: Epoch 2 Full Analysis Set included all participants who received investigational drug at least once in Epoch 2.

Total number of infusion sites injected in Epoch 2 / (duration of Epoch 2 / 30.4375), where duration of Epoch 2 is calculated as the end date of the Epoch 2 - the start date of the Epoch 2 + 1.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Infusion Parameters in Epoch 2: Number of Infusion Sites Per Month	2.02 infusion sites per month Standard Deviation 0.514	—

SECONDARY outcome

Timeframe: From Week 7 up to Week 31 for Participants with 4-Week Dosing Interval or From Week 4 up to Week 28 for Participants with 3-Week Dosing Interval

Population: Epoch 2 Full Analysis Set included all participants who received investigational drug at least once in Epoch 2.

End date and time of infusion in Epoch 2 - Start date and time of infusion in Epoch 2, for each infusion per participant.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Infusion Parameters in Epoch 2: Duration of Individual Infusions	74.0 minutes Interval 18.0 to 207.0	—

SECONDARY outcome

Timeframe: From Week 7 up to Week 31 for Participants with 4-Week Dosing Interval or From Week 4 up to Week 28 for Participants with 3-Week Dosing Interval

Population: Epoch 2 Full Analysis Set included all participants who received investigational drug at least once in Epoch 2.

Maximum Infusion Rate results from CRF / number of infusion sites/body.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Infusion Parameters in Epoch 2: Maximum Infusion Rate Per Site	222.3 mL/hour per site Standard Deviation 83.77	—

SECONDARY outcome

Timeframe: From Week 7 up to Week 31 for Participants with 4-Week Dosing Interval or From Week 4 up to Week 28 for Participants with 3-Week Dosing Interval

Population: Epoch 2 Full Analysis Set included all participants who received investigational drug at least once in Epoch 2. Number analyzed are the number of participants with data available for analysis at given timepoint.

Infusion Volume per Site is scheduled Dose results from CRF / number of infusion sites/body.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Infusion Parameters in Epoch 2: Infusion Volume Per Site	117.3 mL/site Standard Deviation 77.73	—

SECONDARY outcome

Timeframe: 4-Week Dosing Interval (Week 1 and Week 31); 3-Week Dosing Interval (Week 1 and Week 28)

Population: Full Analysis Set included all enrolled participants who received investigational drug at least once. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants available for analysis in the specified category.

The PEDS-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. In this study, 2-7 years (parent as observer), 8-13 years (participant as observer) for PEDS-QL health questionnaire will be analyzed. Higher scores indicate better quality of life (QOL) for all domains of the PEDS-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Four dimensions (physical, emotional, social, \& school functioning) are scored.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=5 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Quality of Life (QOL): Pediatric Quality of Life Inventory (PEDS-QL) Baseline (Week 1), 2-7 years, Total score, 4-week interval	93.48 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant	—
Quality of Life (QOL): Pediatric Quality of Life Inventory (PEDS-QL) Baseline (Week 1), 2-7 years, Total score, 3-week interval	76.09 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant	—
Quality of Life (QOL): Pediatric Quality of Life Inventory (PEDS-QL) Baseline (Week 1), 8-13 years, Total score, 4-week interval	77.17 score on a scale Standard Deviation 18.091	—
Quality of Life (QOL): Pediatric Quality of Life Inventory (PEDS-QL) Change from Baseline (EOS/ET),2-7 years, Total score, 4-week interval	2.17 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
Quality of Life (QOL): Pediatric Quality of Life Inventory (PEDS-QL) Change from Baseline (EOS/ET),2-7 years, Total score, 3-week interval	11.96 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
Quality of Life (QOL): Pediatric Quality of Life Inventory (PEDS-QL) Change from Baseline (EOS/ET), 8-13 years, Total score, 4-week interval	11.41 score on a scale Standard Deviation 3.843	—

SECONDARY outcome

Timeframe: 4-Week Dosing Interval (Week 1 and Week 31); 3-Week Dosing Interval (Week 1 and Week 28)

Population: Epoch 2 Full Analysis Set included all participants who received investigational drug at least once in Epoch 2. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants available for analysis in the specified category.

The SF-36 is a generic quality-of-life instrument that has been widely used to assess Health-Related Quality of Life (HR QoL) of participants. In this study, 14 years and older (participant as observer) for SF-36 health questionnaire will be analyzed. Generic instruments are used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HR QoL. Physical component summary (PCS).

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=8 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Baseline (Week 1), 14 years and older, Physical component summary (PCS) score, 4-week interval	51.85 score on a scale Standard Deviation 3.458	—
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Baseline (Week 1), 14 years and older, Physical component summary (PCS) score, 3-week interval	53.30 score on a scale Standard Deviation 2.546	—
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Baseline (Week 1), 14 years and older, Mental component summary (MCS) score 4-week interval	51.38 score on a scale Standard Deviation 14.060	—
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Baseline (Week 1), 14 years and older, Mental component summary (MCS) score 3-week interval	59.90 score on a scale Standard Deviation 10.465	—
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Baseline (Week 1), >=14 years, Role/social component summary (RCS) score, 4-week interval	49.67 score on a scale Standard Deviation 8.495	—
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Baseline (Week 1), >=14 years, Role/social component summary (RCS) score, 3-week interval	53.50 score on a scale Standard Deviation 8.768	—
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Change from Baseline (EOS/ET), >=14 years, Physical component summary (PCS) score, 4-week interval	0.20 score on a scale Standard Deviation 8.709	—
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Change from Baseline (EOS/ET), >=14 years, Physical component summary (PCS) score, 3-week interval	-1.85 score on a scale Standard Deviation 1.202	—
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Change from Baseline (EOS/ET), >=14 years, Mental component summary (MCS) score 4-week interval	-3.12 score on a scale Standard Deviation 5.605	—
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Change from Baseline (EOS/ET), >=14 years, Mental component summary (MCS) score 3-week interval	-3.55 score on a scale Standard Deviation 0.636	—
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Change from Baseline (EOS/ET), >=14 years, Role/social component summary (RCS) score 4-week interval	-0.80 score on a scale Standard Deviation 6.592	—
QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) Change from Baseline (EOS/ET), >=14 years, Role/social component summary (RCS) score,3-week interval	4.90 score on a scale Standard Deviation 3.394	—

SECONDARY outcome

Timeframe: 4-Week dosing interval (Week 1 and Week 31); 3-Week dosing interval (Week 1 and Week 28)

The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all participants to assess the effect of the treatment on the participants' quality of life. Participants select answer for each of the following 3-level dimensions: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression used to compute an index score ranging from 0 (worst imaginable health state) to 1 (best imaginable health state). An increase in the EQ-5D-3L index score indicates improvement.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=12 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Index Score Baseline (Week 1), 2-11 years, EQ-5D index score, 4-week interval	1.0000 score on a scale Standard Deviation 0.00000	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Index Score Baseline (Week 1), 2-11 years, EQ-5D index score, 3-week interval	0.6750 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Index Score Baseline (Week 1), 12 years and older, EQ-5D index score, 4-week interval	0.9271 score on a scale Standard Deviation 0.12655	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Index Score Baseline (Week 1), 12 years and older, EQ-5D index score, 3-week interval	1 score on a scale Standard Deviation 0	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Index Score Change from Baseline (EOS/ET), 2-11 years, EQ-5D index score, 4-week interval	0.0000 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Index Score Change from Baseline (EOS/ET), 2-11 years, EQ-5D index score, 3-week interval	0.3250 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Index Score Change from Baseline (EOS/ET), 12 years and older, EQ-5D index score, 4-week interval	0.0729 score on a scale Standard Deviation 0.12655	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Index Score Change from Baseline (EOS/ET), 12 years and older, EQ-5D index score, 3-week interval	0.0000 score on a scale Standard Deviation 0.00000	—

SECONDARY outcome

Timeframe: 4-Week dosing interval (Week 1 and Week 31); 3-Week dosing interval (Week 1 and Week 28)

The EQ-5D-3L is a standardized instrument for use as a measure of health outcome and was administered to all participants to assess the effect of the treatment on the participants' quality of life. The EQ-5D-3L includes a visual analog scale (VAS), a vertical scale that allows the participants to indicate their health state that day, and ranges from 0 (worst imaginable) to 100 (best imaginable), with higher scores indicating better health state.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=12 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Visual Analogue Scale (VAS) Score Baseline (Week 1), 2-11 years, EQ-5D VAS score, 4-week interval	95.0 score on a scale Standard Deviation 7.07	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Visual Analogue Scale (VAS) Score Baseline (Week 1), 2-11 years, EQ-5D VAS score, 3-week interval	100.0 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Visual Analogue Scale (VAS) Score Baseline (Week 1), 12 years and older, EQ-5D VAS score, 4-week interval	76.3 score on a scale Standard Deviation 13.24	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Visual Analogue Scale (VAS) Score Baseline (Week 1), 12 years and older, EQ-5D VAS score, 3-week interval	85.0 score on a scale Standard Deviation 7.07	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Visual Analogue Scale (VAS) Score Change from Baseline (EOS/ET), 2-11 years, EQ-5D VAS score, 4-week interval	-5.0 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Visual Analogue Scale (VAS) Score Change from Baseline (EOS/ET), 2-11 years, EQ-5D VAS score, 3-week interval	-10 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Visual Analogue Scale (VAS) Score Change from Baseline (EOS/ET), 12 years and older, EQ-5D VAS score, 4-week interval	6.3 score on a scale Standard Deviation 9.78	—
QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Visual Analogue Scale (VAS) Score Change from Baseline (EOS/ET), 12 years and older, EQ-5D VAS score, 3-week interval	-2.5 score on a scale Standard Deviation 3.54	—

SECONDARY outcome

Timeframe: Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval

Population: Full Analysis Set included all enrolled participants who received investigational drug at least once.

Treatment preference questionnaire is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin (IG) therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the IGSC treatment.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=16 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Treatment Preference 2-13 years, potential to self-administer=Like very much	1 Participants	—
Treatment Preference 2-13 years, potential to self-administer=No preference	2 Participants	—
Treatment Preference 2-13 years, potential to self-administer=Dislike	1 Participants	—
Treatment Preference 2-13 years, potential to self-administer=Dislike very much	1 Participants	—
Treatment Preference 2-13 years, ability to fit my treatment into my own schedule= Like	3 Participants	—
Treatment Preference 2-13 years, ability to fit my treatment into my own schedule= No Preference	2 Participants	—
Treatment Preference 2-13 years, overall convenience=Like	4 Participants	—
Treatment Preference 2-13 years, overall convenience=No preference	1 Participants	—
Treatment Preference 2-13 years, amount of time administration takes=Like	2 Participants	—
Treatment Preference 2-13 years, amount of time administration takes=No preference	2 Participants	—
Treatment Preference 2-13 years, amount of time administration takes=Dislike	1 Participants	—
Treatment Preference 2-13 years, complexity of administration process=Like	2 Participants	—
Treatment Preference 2-13 years, complexity of administration process=No preference	2 Participants	—
Treatment Preference 2-13 years, complexity of administration process=Dislike	1 Participants	—
Treatment Preference 2-13 years, My ability to self-administer without medical supervision=Like very much	1 Participants	—
Treatment Preference 2-13 years, My ability to self-administer without medical supervision=No preference	1 Participants	—
Treatment Preference 2-13 years, My ability to self-administer without medical supervision=Dislike	1 Participants	—
Treatment Preference 2-13 years, My ability to self-administer without medical supervision=Dislike very much	2 Participants	—
Treatment Preference 2-13 years, would you choose to continue receiving your treatment using IGg10% with rHuPH20 SC?=Yes	5 Participants	—
Treatment Preference 14 years and older, Before your participation, where did you receive your IG therapy?=At hospital	8 Participants	—
Treatment Preference 14 years and older, Before your participation, where did you receive your IG therapy?=At home	7 Participants	—
Treatment Preference 14 years and older, Before your participation, where did you receive your IG therapy?=Other	1 Participants	—
Treatment Preference 14 years and older, Where do you prefer to receive your IG therapy? = At hospital	2 Participants	—
Treatment Preference 14 years and older, Where do you prefer to receive your IG therapy? = At home	7 Participants	—
Treatment Preference 14 years and older, Where do you prefer to receive your IG therapy? = No preference	2 Participants	—
Treatment Preference 14 years and older, frequency of administration=Like very much	3 Participants	—
Treatment Preference 14 years and older, frequency of administration=Like	7 Participants	—
Treatment Preference 14 years and older, frequency of administration=No preference	1 Participants	—
Treatment Preference 14 years and older, number of needlesticks per month=Like	8 Participants	—
Treatment Preference 14 years and older, number of needlesticks per month=No preference	3 Participants	—
Treatment Preference 14 years and older, total time spent for my treatment per month = Like very much	1 Participants	—
Treatment Preference 14 years and older, total time spent for my treatment per month=Like	6 Participants	—
Treatment Preference 14 years and older, total time spent for my treatment per month=No preference	2 Participants	—
Treatment Preference 14 years and older, total time spent for my treatment per month=Dislike	2 Participants	—
Treatment Preference 14 years and older, ease of administration=Like	2 Participants	—
Treatment Preference 14 years and older, ease of administration=No preference	2 Participants	—
Treatment Preference 14 years and older, ease of administration=Dislike	6 Participants	—
Treatment Preference 14 years and older, ease of administration=Dislike very much	1 Participants	—
Treatment Preference 14 years and older, potential to self-administer=Like	8 Participants	—
Treatment Preference 14 years and older, The potential to self-administer = No preference	1 Participants	—
Treatment Preference 14 years and older, potential to self-administer=Dislike	1 Participants	—
Treatment Preference 14 years and older, potential to self-administer=Dislike very much	1 Participants	—
Treatment Preference 14 years and older, ability to fit my treatment into my own schedule= Like very much	1 Participants	—
Treatment Preference 14 years and older, ability to fit my treatment into my own schedule= Like	7 Participants	—
Treatment Preference 14 years and older, ability to fit my treatment into my own schedule= No preference	2 Participants	—
Treatment Preference 14 years and older, ability to fit my treatment into my own schedule= Dislike	1 Participants	—
Treatment Preference 14 years and older, overall convenience = Like	8 Participants	—
Treatment Preference 14 years and older, overall convenience = No preference	2 Participants	—
Treatment Preference 14 years and older, overall convenience = Dislike	1 Participants	—
Treatment Preference 14 years and older, amount of time administration takes = Like	7 Participants	—
Treatment Preference 14 years and older, amount of time administration takes = No preference	3 Participants	—
Treatment Preference 14 years and older, amount of time administration takes = Dislike	1 Participants	—
Treatment Preference 14 years and older, complexity of administration process=Like very much	1 Participants	—
Treatment Preference 14 years and older, complexity of administration process=Like	1 Participants	—
Treatment Preference 14 years and older, complexity of administration process=No preference	2 Participants	—
Treatment Preference 14 years and older, complexity of administration process=Dislike	6 Participants	—
Treatment Preference 14 years and older, complexity of administration process=Dislike very much	1 Participants	—
Treatment Preference 14 years and older, My ability to self-administer without medical supervision=Like very much	1 Participants	—
Treatment Preference 14 years and older, My ability to self-administer without medical supervision=Like	6 Participants	—
Treatment Preference 14 years and older, My ability to self-administer without medical supervision = No preference	1 Participants	—
Treatment Preference 14 years and older, My ability to self-administer without medical supervision = Dislike	2 Participants	—
Treatment Preference 14 years and older, My ability to self-administer without medical supervision = Dislike very much	1 Participants	—
Treatment Preference 14 years and older, choose to continue receiving your treatment using IGg 10% with rHuPH20 SC?=Yes	9 Participants	—
Treatment Preference 14 years and older, choose to continue receiving your treatment using IGg 10% with rHuPH20 SC?= No	2 Participants	—
Treatment Preference 2-13 years, Before your participation in the trial, where did you receive your IG therapy?=At home	2 Participants	—
Treatment Preference 2-13 years, Where do you prefer to receive your immunoglobulin therapy?=At hospital	2 Participants	—
Treatment Preference 2-13 years, Where do you prefer to receive your IG therapy?=At home	1 Participants	—
Treatment Preference 2-13 years, Where do you prefer to receive your IG therapy?=No Preference	2 Participants	—
Treatment Preference 2-13 years, frequency of administration=Like very much	3 Participants	—
Treatment Preference 2-13 years, frequency of administration=Like	1 Participants	—
Treatment Preference 2-13 years, Frequency of administration=No Preference	1 Participants	—
Treatment Preference 2-13 years, number of needlesticks per month=Like very much	2 Participants	—
Treatment Preference 2-13 years, number of needlesticks per month=Like	2 Participants	—
Treatment Preference 2-13 years, number of needlesticks per month=No preference	1 Participants	—
Treatment Preference 2-13 years, total time spent for my treatment per month=Like	3 Participants	—
Treatment Preference 2-13 years, total time spent for my treatment per month=No Preference	2 Participants	—
Treatment Preference 2-13 years, ease of administration= Like	1 Participants	—
Treatment Preference 2-13 years, ease of administration= No Preference	3 Participants	—
Treatment Preference 2-13 years, The ease of administration= Dislike	1 Participants	—
Treatment Preference 2-13 years, Before your participation in trial, where did you receive your IG therapy?=At hospital	4 Participants	—

SECONDARY outcome

Timeframe: 4-Week dosing interval (Week 1 and Week 31); 3-Week dosing interval (Week 1 and Week 28)

Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. In this study, 2-12 years (parent as observer), 13 years and older (participant as observer) for TSQM health questionnaire will be analyzed. TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.

Outcome measures

Outcome measures
Measure	Epoch 2: TAK-771 Full Dose Treatment Period n=12 Participants TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.	Epoch 2: TAK-771 Full Dose Treatment Period TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 27 for participants with 4-Week dosing interval or Week 25 for participants with 3-Week dosing interval.
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 2-12 years, Effectiveness, 4-week interval	64.81 score on a scale Standard Deviation 3.208	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 2-12 years, Effectiveness, 3-week interval	94.44 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 2-12 years, Convenience, 4-week interval	44.44 score on a scale Standard Deviation 19.245	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 2-12 years, Convenience, 3-week interval	38.89 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 2-12 years, Global satisfaction, 4-week interval	59.52 score on a scale Standard Deviation 10.911	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 2-12 years, Global satisfaction, 3-week interval	100.00 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 13 years and older, Effectiveness, 4-week interval	64.81 score on a scale Standard Deviation 18.812	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 13 years and older, Effectiveness, 3-week interval	63.89 score on a scale Standard Deviation 3.928	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 13 years and older, Convenience, 4-week interval	62.04 score on a scale Standard Deviation 19.694	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 13 years and older, Convenience, 3-week interval	44.44 score on a scale Standard Deviation 0.000	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 13 years and older, Global satisfaction, 4-week interval	60.71 score on a scale Standard Deviation 8.748	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Baseline (Week 1), 13 years and older, Global satisfaction, 3-week interval	64.29 score on a scale Standard Deviation 10.102	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 2-12 years, Effectiveness, 4-week interval	0.00 score on a scale Standard Deviation 0.000	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 2-12 years, Effectiveness, 3-week interval	-27.78 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 2-12 years, Convenience, 4-week interval	13.89 score on a scale Standard Deviation 3.928	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 2-12 years, Convenience, 3-week interval	0.00 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 2-12 years, Global satisfaction, 4-week interval	10.71 score on a scale Standard Deviation 5.051	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 2-12 years, Global satisfaction, 3-week interval	-28.57 score on a scale Standard Deviation NA Standard deviation is not estimable for single participant.	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 13 years and older, Effectiveness, 4-week interval	-12.04 score on a scale Standard Deviation 26.156	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 13 years and older, Effectiveness, 3-week interval	2.78 score on a scale Standard Deviation 3.928	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 13 years and older, Convenience, 4-week interval	-3.70 score on a scale Standard Deviation 20.688	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 13 years and older, Convenience, 3-week interval	0.00 score on a scale Standard Deviation 7.857	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 13 years and older, Global satisfaction, 4-week interval	-13.10 score on a scale Standard Deviation 26.885	—
Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) Change from Baseline (EOS/ET), 13 years and older, Global satisfaction, 3-week interval	-3.57 score on a scale Standard Deviation 5.051	—

Adverse Events

Epoch 1: TAK-771 Ramp up Period

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Epoch 2: TAK-771 Full Dose Treatment Period

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Epoch 1: TAK-771 Ramp up Period n=16 participants at risk TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of 10% IGI was increased from 1/3 of full dose to full dose in 3 weeks for participants who received TAK-771 once every 3 weeks, or from 1/4 of full dose to full dose in 6 weeks for participants who received TAK-771 once every 4 weeks.	Epoch 2: TAK-771 Full Dose Treatment Period n=16 participants at risk TAK-771 included IGI 10% and rHuPH20. Participants received subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 24.
Endocrine disorders Adrenal insufficiency	6.2% 1/16 • From study start up to Week 28 for the 3-week dosing intervals and up to Week 31 for 4-week dosing intervals Safety analysis set included all enrolled participants who received investigational drug at least once. Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.	0.00% 0/16 • From study start up to Week 28 for the 3-week dosing intervals and up to Week 31 for 4-week dosing intervals Safety analysis set included all enrolled participants who received investigational drug at least once. Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.
Infections and infestations Gastroenteritis	6.2% 1/16 • From study start up to Week 28 for the 3-week dosing intervals and up to Week 31 for 4-week dosing intervals Safety analysis set included all enrolled participants who received investigational drug at least once. Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.	0.00% 0/16 • From study start up to Week 28 for the 3-week dosing intervals and up to Week 31 for 4-week dosing intervals Safety analysis set included all enrolled participants who received investigational drug at least once. Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/16 • From study start up to Week 28 for the 3-week dosing intervals and up to Week 31 for 4-week dosing intervals Safety analysis set included all enrolled participants who received investigational drug at least once. Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.	6.2% 1/16 • From study start up to Week 28 for the 3-week dosing intervals and up to Week 31 for 4-week dosing intervals Safety analysis set included all enrolled participants who received investigational drug at least once. Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2.

Other adverse events

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER