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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031210457 | Registry Identifier | jRCT |
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The main aim of the study is to check how much TAK-771 stays in their blood over time, side effect from the study treatment or TAK-771, how much TAK-771 participants can receive without getting side effects from it, and if TAK-771 improves symptoms of primary immunodeficiency diseases (PID). This will help the study sponsor (Takeda) to work out the best dose to give people in the future.
The participants will be treated with TAK-771 for totally 27 or 30 weeks. Treatment period is consist of two periods called Epoch 1 and Epoch 2. In Epoch 1, different groups of participants will receive lower to higher doses of TAK-771 for 3 to 6 weeks. The study doctors will check for side effects from each dose of TAK-771. In Epoch 2, participants will receive TAK-771 once a 3 or 4 weeks until the end of 24 weeks.
There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug (every 3, or 4 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epoch 1: TAK-771 Ramp up Period | Experimental | 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. |
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| Epoch 2: TAK-771 Full Dose Treatment Period | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-771 | Drug | Intervention description; Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 | 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. | Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval |
| Measure | Description | Time Frame |
|---|---|---|
| Epoch 2: Maximum Concentration (Cmax) of Total Serum Levels of IgG and IgG Subclasses | 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. | |
| Epoch 2: Time to Maximum Concentration (Tmax) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) |
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Inclusion Criteria
Be a Japanese person.
Participant must have a documented diagnosis of a form of primary humoral immunodeficiency involving antibody formation and requiring gammaglobulin replacement, as defined according to the International Union of Immunological Societies(IUIS) Committee 2017. The diagnosis must be confirmed by the Medical Director prior to TAK-771 treatment.
Participant has been receiving a stable clinical dose of intravenous immunoglobulin (IVIG) or conventional subcutaneous immunoglobulin (cSCIG), which is equivalent to approximately 200 to 600 mg/kg body weight per 3 to 4 week period for IVIG and approximately 50 to 200 mg/kg body weight per week for cSCIG based on the description in the package insert, consistently over a period of at least 3 months prior to screening, or Participant has been receiving of TAK-664 with fixed dose and dosing frequency at least 3 months prior to enrollment. That is, participant is about to complete Study TAK-664-3001 or participating in Study TAK-664-3002.
Participant who has been receiving IVIG or cSCIG had all serum trough levels of total immunoglobulin G (IgG) >=5 g/L within 1 month prior to the screening/enrollment.
Serum trough levels at screening/enrollment meet one of the following:
Participant is willing and able to comply with use of digital tools and applications.
Exclusion Criteria
Participant has a known history of or is positive at screening/enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2 For participants who are switching from TAK-664 studies, the eligibility will be reconfirmed after result of the specialty test conducted at Week 1 become available.
Abnormal laboratory values at screening/enrollment meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):
Participant has presence of renal function impairment defined by eGFR <60 mL/min/1.73m^2.
Participant has been diagnosed with, or had a malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the disease-free period prior to screening exceeds 5 years.
Participant is receiving anti-coagulation therapy or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within 12 months prior to screening/enrollment or a history of thrombophilia.
Participant has abnormal protein loss (protein losing enteropathy, nephrotic syndrome)
Participant has anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site.
Participant has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IVIG, subcutaneous immunoglobulin (SCIG), and/or Immune Serum Globulin infusions
Participant has immunoglobulin A (IgA) deficiency (serum IgA less than 0.07g/L) and history of hypersensitivity, or history of confirmed anti-IgA antibodies, or both.
Participant is on preventative (prophylactic) systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and cannot stop these antibiotics at the time of screening/enrollment.
Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening/enrollment or had a serious bacterial infection within the 3 months prior to screening/enrollment
Participant has a bleeding disorder, or a platelet count less than 20,000/microL, or in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of subcutaneous (SC) therapy.
Participant has total protein >9 g/dL or myeloma, or macroglobulinemia (IgM) or paraproteinemia.
Participant has a known allergy to hyaluronidase
Participant has severe dermatitis that would preclude adequate sites for safe product administration.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Nagoya | Aichi-ken | Japan | |||
| Hospital of University of Occupational and Environmental Health |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Epoch 1 |
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| Epoch 2 |
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Safety Analysis Set (SAS) included all enrolled subjects who received investigational drug at least once. Analyses of safety, tolerability and product administration were based on the SAS.
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| ID | Title | Description |
|---|---|---|
| BG000 | Epoch 1: TAK-771 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Epoch 2: Serum Trough Levels of Total IgG Antibodies After Administration of TAK-771 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | grams/Liter (g/L) | Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epoch 1: TAK-771 Ramp up 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenal insufficiency | Endocrine disorders | MedDRA 26 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2022 | Feb 18, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2023 | Feb 18, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| 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. |
| Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) | AUC is expressed as grams*day per liter/grams per kilograms [(g*day/L)/(g/kg)]. | 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. |
| Epoch 2: Half-life of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) | 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 |
| Epoch 2: Apparent Total Clearance (CL/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) | 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. |
| Epoch 2: Apparent Volume of Distribution (Vz/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) | 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. |
| Epoch 2: Minimum Concentration (Cmin) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) | 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. |
| Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 | 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) |
| Epoch 1 and 2: Trough Levels of Anti-Clostridium Tetani Toxoid Antibody After Administration of TAK-771 | 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) |
| Epoch 1 and 2: Trough Levels of Anti-HBV Antibody After Administration of TAK-771 | 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) |
| Epoch 1 and 2: Trough Levels of Anti-HIB Antibody After Administration of TAK-771 | 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). |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | 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 |
| Percentage of Participants With TAK-771-Related and TAK-771-Non-Related TEAEs | 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. | 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 |
| Percentage of Participants With Serious and Non-serious TEAEs | 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. | 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 |
| Percentage of Participants With Severe TEAEs | 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 |
| Percentage of Participants With Local and Systemic TEAEs | 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 |
| Percentage of Participants With TEAEs Leading to Premature Discontinuation From Study | 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 |
| Percentage of Participants With Infusion-associated TEAEs | 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 |
| Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Parameters Recorded as TEAEs | 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 |
| Percentage of Participants With Clinically Significant Changes in Vital Signs and Body Weight Recorded as TEAEs | 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 |
| Epoch 2: Percentage of Participants Who Develop Anti-rHuPH20 Binding Antibody Titers of Greater Than or Equal to 1:160 | 4-Week Dosing Interval (Week 7, Week 19, and Week 31); 3-Week Dosing Interval (Week 4, Week 16, and Week 28) |
| Epoch 2: Percentage of Participants Who Develop Neutralizing Antibodies to rHuPH20 | 4-Week Dosing Interval (Week 7, Week 19, and Week 31); 3-Week Dosing Interval (Week 4, Week 16, and Week 28) |
| Percentage of Participants Who Experienced Tolerability Events Related to the Infusion of TAK-771 | 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. | 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 |
| Epoch 1: Number of Weeks to Reach Final Dose Interval (3 Weeks or 4 Weeks) | The number of weeks to reach final dose interval is defined as treatment duration of Epoch 1. | Up to Week 4 for Participants with 4-Week Dosing Interval or Up to Week 3 for Participants with 3-Week Dosing Interval |
| Epoch 2: Percentage of Participants Who Achieve a Treatment Interval of 3 or 4 Weeks | Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval |
| Epoch 2: Percentage of Participants Who Maintain a Treatment Interval of 3 or 4 Weeks | Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval |
| Annual Rate of Validated Acute Serious Bacterial Infections (ASBIs) Per Participant Per Year | The annual rate of validated ASBIs is calculated as the mean number of ASBIs per participant per year. | 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 |
| Annual Rate of All Infections Per Participant Per Year | The annual rate of all infections is calculated as the mean number of infections per participant per year. | 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 |
| Healthcare Resource Utilization: Days Not Able To Attend School/Work or To Perform Normal Daily Activities Due to Illness/Infection | 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 |
| Healthcare Resource Utilization: Days on Antibiotics | 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 |
| Healthcare Resource Utilization: Number of Hospitalizations Due to Illness/Infection Per Year | 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 |
| Healthcare Resource Utilization: Length of Stay in Days of Hospitalizations Due to Illness/Infection Per Participant Per Year | 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 |
| Healthcare Resource Utilization: Number of Acute (Urgent or Unscheduled) Physician Visits Due to Illness/Infection | 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 |
| Infusion Parameters in Epoch 2: Number of Infusion Sites Per Infusion | Total number of infusion sites injected in Epoch 2 / Total number of infusions administered in Epoch 2. | 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 |
| Infusion Parameters in Epoch 2: Number of Infusion Sites Per Month | 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. | 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 |
| Infusion Parameters in Epoch 2: Duration of Individual Infusions | End date and time of infusion in Epoch 2 - Start date and time of infusion in Epoch 2, for each infusion per participant. | 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 |
| Infusion Parameters in Epoch 2: Maximum Infusion Rate Per Site | Maximum Infusion Rate results from CRF / number of infusion sites/body. | 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 |
| Infusion Parameters in Epoch 2: Infusion Volume Per Site | Infusion Volume per Site is scheduled Dose results from CRF / number of infusion sites/body. | 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 |
| Quality of Life (QOL): Pediatric Quality of Life Inventory (PEDS-QL) | 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. | 4-Week Dosing Interval (Week 1 and Week 31); 3-Week Dosing Interval (Week 1 and Week 28) |
| QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) | 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). | 4-Week Dosing Interval (Week 1 and Week 31); 3-Week Dosing Interval (Week 1 and Week 28) |
| QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Index Score | 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. | 4-Week dosing interval (Week 1 and Week 31); 3-Week dosing interval (Week 1 and Week 28) |
| QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Visual Analogue Scale (VAS) Score | 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. | 4-Week dosing interval (Week 1 and Week 31); 3-Week dosing interval (Week 1 and Week 28) |
| Treatment Preference | 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. | Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval |
| Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) | 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. | 4-Week dosing interval (Week 1 and Week 31); 3-Week dosing interval (Week 1 and Week 28) |
| Kitakyushu |
| Fukuoka |
| Japan |
| Kurume University Hospital | Kurume | Fukuoka | Japan |
| Kanagawa Children's Medical Center | Yokohama | Kanagawa | Japan |
| Shinshu University Hospital | Matsumoto | Nagano | Japan |
| Tokyo Medical Dental University Hospital | Bunkyo-ku | Tokyo | Japan |
| National Center for Child Health and development | Setagaya-ku | Tokyo | Japan |
| Kyushu University Hospital | Fukuoka | Japan |
| Gifu University Hospital | Gifu | Japan |
| Hiroshima University Hospital | Hiroshima | Japan |
| Saitama Prefectual Children's Medical Center | Saitama | Japan |
| Shizuoka Childrens Hospital | Shizuoka | Japan |
| Pharmacokinetic Analysis Set 2 | 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 participants. (N=16). There were 4 participants aged 12 years or older who consented to blood sampling for analysis of PK parameters, and Pharmacokinetic Analysis Set 2 analysis was performed on a subset consisting of these 4 participants. |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Height at Baseline | Mean | Standard Deviation | Centimeters (cm) |
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| Weight at Baseline | Mean | Standard Deviation | Kilograms (kg) |
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| Body Mass Index (BMI) | BMI=weight (kg) / [height (m)]^2 | Mean | Standard Deviation | kilograms per meter square (kg/m^2) |
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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. |
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| Secondary | Epoch 2: Maximum Concentration (Cmax) of Total Serum Levels of IgG and IgG Subclasses | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | g/L | 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. |
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| Secondary | Epoch 2: Time to Maximum Concentration (Tmax) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) | 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. | Posted | Median | Full Range | days | 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. |
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| Secondary | Epoch 2: Area Under the Curve (AUC) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) | AUC is expressed as grams*day per liter/grams per kilograms [(g*day/L)/(g/kg)]. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | (g*day/L)/(g/kg) | 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. |
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| Secondary | Epoch 2: Half-life of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) | 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 is number of participant available for analysis. | Posted | Median | Full Range | day | 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 |
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| Secondary | Epoch 2: Apparent Total Clearance (CL/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliters per day (mL/day) | 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. |
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| Secondary | Epoch 2: Apparent Volume of Distribution (Vz/F) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL | 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. |
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| Secondary | Epoch 2: Minimum Concentration (Cmin) of Total Serum Levels of IgG and IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | g/L | 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. |
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| Secondary | Epoch 2: Serum Trough Levels of IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) After Administration of TAK-771 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | g/L | 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) |
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| Secondary | Epoch 1 and 2: Trough Levels of Anti-Clostridium Tetani Toxoid Antibody After Administration of TAK-771 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | IU/mL | 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) |
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| Secondary | Epoch 1 and 2: Trough Levels of Anti-HBV Antibody After Administration of TAK-771 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mIU/mL | 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) |
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| Secondary | Epoch 1 and 2: Trough Levels of Anti-HIB Antibody After Administration of TAK-771 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | 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). |
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| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | Percentage of Participants With TAK-771-Related and TAK-771-Non-Related TEAEs | 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. | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | Percentage of Participants With Serious and Non-serious TEAEs | 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. | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | Percentage of Participants With Severe TEAEs | 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. | Posted | Number | Percentage of participants | 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 |
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| Secondary | Percentage of Participants With Local and Systemic TEAEs | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | Percentage of Participants With TEAEs Leading to Premature Discontinuation From Study | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | Percentage of Participants With Infusion-associated TEAEs | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Parameters Recorded as TEAEs | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | Percentage of Participants With Clinically Significant Changes in Vital Signs and Body Weight Recorded as TEAEs | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | Epoch 2: Percentage of Participants Who Develop Anti-rHuPH20 Binding Antibody Titers of Greater Than or Equal to 1:160 | Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2. | Posted | Number | percentage of participants | 4-Week Dosing Interval (Week 7, Week 19, and Week 31); 3-Week Dosing Interval (Week 4, Week 16, and Week 28) |
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| Secondary | Epoch 2: Percentage of Participants Who Develop Neutralizing Antibodies to rHuPH20 | Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2. | Posted | Number | percentage of participants | 4-Week Dosing Interval (Week 7, Week 19, and Week 31); 3-Week Dosing Interval (Week 4, Week 16, and Week 28) |
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| Secondary | Percentage of Participants Who Experienced Tolerability Events Related to the Infusion of TAK-771 | 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. | 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. | Posted | Number | percentage of participants | 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 |
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| Secondary | Epoch 1: Number of Weeks to Reach Final Dose Interval (3 Weeks or 4 Weeks) | The number of weeks to reach final dose interval is defined as treatment duration of Epoch 1. | Safety Analysis Set included all enrolled participants who received investigational drug at least once. | Posted | Median | Full Range | weeks | Up to Week 4 for Participants with 4-Week Dosing Interval or Up to Week 3 for Participants with 3-Week Dosing Interval |
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| Secondary | Epoch 2: Percentage of Participants Who Achieve a Treatment Interval of 3 or 4 Weeks | Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2. | Posted | Number | percentage of participants | Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval |
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| Secondary | Epoch 2: Percentage of Participants Who Maintain a Treatment Interval of 3 or 4 Weeks | Epoch 2 Safety Analysis Set included all participants who received investigational drug at least once in Epoch 2. | Posted | Number | percenatge of participants | Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval |
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| Secondary | Annual Rate of Validated Acute Serious Bacterial Infections (ASBIs) Per Participant Per Year | The annual rate of validated ASBIs is calculated as the mean number of ASBIs per participant per year. | Full Analysis Set included all enrolled participants who received investigational drug at least once. | Posted | Mean | Standard Deviation | ASBIs per participant per year | 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 |
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| Secondary | Annual Rate of All Infections Per Participant Per Year | The annual rate of all infections is calculated as the mean number of infections per participant per year. | Full Analysis Set included all enrolled participants who received investigational drug at least once. | Posted | Mean | Standard Deviation | infections per participant per year | 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 |
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| Secondary | Healthcare Resource Utilization: Days Not Able To Attend School/Work or To Perform Normal Daily Activities Due to Illness/Infection | Full Analysis Set included all enrolled participants who received investigational drug at least once. | Posted | Median | Full Range | number of days | 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 |
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| Secondary | Healthcare Resource Utilization: Days on Antibiotics | Full Analysis Set included all enrolled participants who received investigational drug at least once. | Posted | Median | Full Range | number of days | 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 |
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| Secondary | Healthcare Resource Utilization: Number of Hospitalizations Due to Illness/Infection Per Year | Full Analysis Set included all enrolled participants who received investigational drug at least once. | Posted | Mean | Standard Deviation | hospitalizations per year | 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 |
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| Secondary | Healthcare Resource Utilization: Length of Stay in Days of Hospitalizations Due to Illness/Infection Per Participant Per Year | Full Analysis Set included all enrolled participants who received investigational drug at least once. | Posted | Median | Full Range | hospitalization days/participant/year | 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 |
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| Secondary | Healthcare Resource Utilization: Number of Acute (Urgent or Unscheduled) Physician Visits Due to Illness/Infection | Full Analysis Set included all enrolled participants who received investigational drug at least once. | Posted | Median | Full Range | Acute Physician Visits | 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 |
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| Secondary | Infusion Parameters in Epoch 2: Number of Infusion Sites Per Infusion | Total number of infusion sites injected in Epoch 2 / Total number of infusions administered in Epoch 2. | Epoch 2 Full Analysis Set included all participants who received investigational drug at least once in Epoch 2. | Posted | Mean | Standard Deviation | infusion sites per infusion | 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 |
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| Secondary | Infusion Parameters in Epoch 2: Number of Infusion Sites Per Month | 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. | Epoch 2 Full Analysis Set included all participants who received investigational drug at least once in Epoch 2. | Posted | Mean | Standard Deviation | infusion sites per month | 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 |
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| Secondary | Infusion Parameters in Epoch 2: Duration of Individual Infusions | End date and time of infusion in Epoch 2 - Start date and time of infusion in Epoch 2, for each infusion per participant. | Epoch 2 Full Analysis Set included all participants who received investigational drug at least once in Epoch 2. | Posted | Median | Full Range | minutes | 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 |
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| Secondary | Infusion Parameters in Epoch 2: Maximum Infusion Rate Per Site | Maximum Infusion Rate results from CRF / number of infusion sites/body. | Epoch 2 Full Analysis Set included all participants who received investigational drug at least once in Epoch 2. | Posted | Mean | Standard Deviation | mL/hour per site | 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 |
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| Secondary | Infusion Parameters in Epoch 2: Infusion Volume Per Site | Infusion Volume per Site is scheduled Dose results from CRF / number of infusion sites/body. | 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. | Posted | Mean | Standard Deviation | mL/site | 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 |
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| Secondary | Quality of Life (QOL): Pediatric Quality of Life Inventory (PEDS-QL) | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 4-Week Dosing Interval (Week 1 and Week 31); 3-Week Dosing Interval (Week 1 and Week 28) |
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| Secondary | QOL: Short Form-36 Health Survey Version 2 (SF-36 v2) | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | 4-Week Dosing Interval (Week 1 and Week 31); 3-Week Dosing Interval (Week 1 and Week 28) |
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| Secondary | QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Index Score | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 4-Week dosing interval (Week 1 and Week 31); 3-Week dosing interval (Week 1 and Week 28) |
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| Secondary | QOL: EuroQoL (Quality of Life)-5 Dimensions 3 Levels (EQ-5D-3L) Health Questionnaire Visual Analogue Scale (VAS) Score | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 4-Week dosing interval (Week 1 and Week 31); 3-Week dosing interval (Week 1 and Week 28) |
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| Secondary | Treatment Preference | 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. | Full Analysis Set included all enrolled participants who received investigational drug at least once. | Posted | Count of Participants | Participants | Up to Week 31 for Participants with 4-Week Dosing Interval or Up to Week 28 for Participants with 3-Week Dosing Interval |
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| Secondary | Treatment Satisfaction: Questionnaire for Medication-9 (TSQM-9) | 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. | 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 with data available for analysis at given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 4-Week dosing interval (Week 1 and Week 31); 3-Week dosing interval (Week 1 and Week 28) |
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| 0 |
| 16 |
| 1 |
| 16 |
| 13 |
| 16 |
| EG001 | 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 24. | 0 | 16 | 1 | 16 | 15 | 16 |
| Gastroenteritis | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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| Administration site pain | General disorders | MedDRA 26 | Systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 26 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
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| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Chronic sinusitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | MedDRA 26 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 26 | Systematic Assessment |
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| Faeces soft | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26 | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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| Gingival swelling | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA 26 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 26 | Systematic Assessment |
|
| Infusion site swelling | General disorders | MedDRA 26 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 26 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 26 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 26 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 26 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 26 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 26 | Systematic Assessment |
|
| Oedema genital | Reproductive system and breast disorders | MedDRA 26 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 26 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 26 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 26 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 26 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 26 | Systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26 | Systematic Assessment |
|
| Vaccination site pain | General disorders | MedDRA 26 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 26 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
|
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.
| Title | Measurements |
|---|---|
|
| IgG Subclass (IgG 3) |
|
| IgG Subclass (IgG 4) |
|
| Title | Measurements |
|---|---|
|
| IgG Subclass (IgG 3) |
|
| IgG Subclass (IgG 4) |
|
|
| IgG Subclass (IgG 1), AUCtau/Dose |
|
|
| IgG Subclass (IgG 1), AUClast/Dose |
|
|
| IgG Subclass (IgG 2), AUCtau/Dose |
|
|
| IgG Subclass (IgG 2), AUClast/Dose |
|
|
| IgG Subclass (IgG 3), AUCtau/Dose |
|
|
| IgG Subclass (IgG 3), AUClast/Dose |
|
|
| IgG Subclass (IgG 4), AUCtau/Dose |
|
|
| IgG Subclass (IgG 4), AUClast/Dose |
|
|
|
| IgG Subclass (IgG 2) |
|
|
| IgG Subclass (IgG 3) |
|
|
| IgG Subclass (IgG 4) |
|
|
|
| IgG Subclass (IgG 2) |
|
|
| IgG Subclass (IgG 3) |
|
|
| IgG Subclass (IgG 4) |
|
|
|
| IgG Subclass (IgG 2) |
|
|
| IgG Subclass (IgG 3) |
|
|
| IgG Subclass (IgG 4) |
|
|
|
| IgG Subclass (IgG 2) |
|
|
| IgG Subclass (IgG 3) |
|
|
| IgG Subclass (IgG 4) |
|
|
|
| IgG 1, Week 15, 4-Week Interval |
|
|
| IgG 1, Week 19, 4-Week Interval |
|
|
| IgG 1, Week 23, 4-Week Interval |
|
|
| IgG 1, Week 27, 4-Week Interval |
|
|
| IgG 1, Week 31, 4-Week Interval |
|
|
| IgG 2, Week 7, 4-Week Interval |
|
|
| IgG 2, Week 11, 4-Week Interval |
|
|
| IgG 2, Week 15, 4-Week Interval |
|
|
| IgG 2, Week 19, 4-Week Interval |
|
|
| IgG 2, Week 23, 4-Week Interval |
|
|
| IgG 2, Week 27, 4-Week Interval |
|
|
| IgG 2, Week 31, 4-Week Interval |
|
|
| IgG 3, Week 7, 4-Week Interval |
|
|
| IgG 3, Week 11, 4-Week Interval |
|
|
| IgG 3, Week 15, 4-Week Interval |
|
|
| IgG 3, Week 19, 4-Week Interval |
|
| IgG 3, Week 23, 4-Week Interval |
|
| IgG 3, Week 27, 4-Week Interval |
|
|
| IgG 3, Week 31, 4-Week Interval |
|
| IgG 4, Week 7, 4-Week Interval |
|
|
| IgG 4, Week 11, 4-Week Interval |
|
|
| IgG 4, Week 15, 4-Week Interval |
|
|
| IgG 4, Week 19, 4-Week Interval |
|
|
| IgG 4, Week 23, 4-Week Interval |
|
|
| IgG 4, Week 27, 4-Week Interval |
|
|
| IgG 4, Week 31, 4-Week Interval |
|
|
| IgG 1, Week 4, 3-Week Interval |
|
|
| IgG 1, Week 7, 3-Week Interval |
|
|
| IgG 1, Week 10, 3-Week Interval |
|
|
| IgG 1, Week 13, 3-Week Interval |
|
| IgG 1, Week 16, 3-Week Interval |
|
|
| IgG 1, Week 19, 3-Week Interval |
|
|
| IgG 1, Week 22, 3-Week Interval |
|
|
| IgG 1, Week 25, 3-Week Interval |
|
|
| IgG 1, Week 28, 3-Week Interval |
|
|
| IgG 2, Week 4, 3-Week Interval |
|
|
| IgG 2, Week 7, 3-Week Interval |
|
|
| IgG 2, Week 10, 3-Week Interval |
|
|
| IgG 2, Week 13, 3-Week Interval |
|
| IgG 2, Week 16, 3-Week Interval |
|
|
| IgG 2, Week 19, 3-Week Interval |
|
|
| IgG 2, Week 22, 3-Week Interval |
|
|
| IgG 2, Week 25, 3-Week Interval |
|
|
| IgG 2, Week 28, 3-Week Interval |
|
|
| IgG 3, Week 4, 3-Week Interval |
|
| IgG 3, Week 7, 3-Week Interval |
|
| IgG 3, Week 10, 3-Week Interval |
|
| IgG 3, Week 13, 3-Week Interval |
|
| IgG 3, Week 16, 3-Week Interval |
|
| IgG 3, Week 19, 3-Week Interval |
|
| IgG 3, Week 22, 3-Week Interval |
|
| IgG 3, Week 25, 3-Week Interval |
|
| IgG 3, Week 28, 3-Week Interval |
|
| IgG 4, Week 4, 3-Week Interval |
|
|
| IgG 4, Week 7, 3-Week Interval |
|
|
| IgG 4, Week 10, 3-Week Interval |
|
|
| IgG 4, Week 13, 3-Week Interval |
|
| IgG 4, Week 16, 3-Week Interval |
|
|
| IgG 4, Week 19, 3-Week Interval |
|
|
| IgG 4, Week 22, 3-Week Interval |
|
|
| IgG 4, Week 25, 3-Week Interval |
|
|
| IgG 4, Week 28, 3-Week Interval |
|
|
|
|
|
|
| Baseline (Week 1), 8-13 years, Total score, 4-week interval |
|
|
| Change from Baseline (EOS/ET),2-7 years, Total score, 4-week interval |
|
|
| Change from Baseline (EOS/ET),2-7 years, Total score, 3-week interval |
|
|
| Change from Baseline (EOS/ET), 8-13 years, Total score, 4-week interval |
|
|
|
| Baseline (Week 1), 14 years and older, Mental component summary (MCS) score 4-week interval |
|
|
| Baseline (Week 1), 14 years and older, Mental component summary (MCS) score 3-week interval |
|
|
| Baseline (Week 1), >=14 years, Role/social component summary (RCS) score, 4-week interval |
|
|
| Baseline (Week 1), >=14 years, Role/social component summary (RCS) score, 3-week interval |
|
|
| Change from Baseline (EOS/ET), >=14 years, Physical component summary (PCS) score, 4-week interval |
|
|
| Change from Baseline (EOS/ET), >=14 years, Physical component summary (PCS) score, 3-week interval |
|
|
| Change from Baseline (EOS/ET), >=14 years, Mental component summary (MCS) score 4-week interval |
|
|
| Change from Baseline (EOS/ET), >=14 years, Mental component summary (MCS) score 3-week interval |
|
|
| Change from Baseline (EOS/ET), >=14 years, Role/social component summary (RCS) score 4-week interval |
|
|
| Change from Baseline (EOS/ET), >=14 years, Role/social component summary (RCS) score,3-week interval |
|
|
|
| Baseline (Week 1), 12 years and older, EQ-5D index score, 4-week interval |
|
|
| Baseline (Week 1), 12 years and older, EQ-5D index score, 3-week interval |
|
|
| Change from Baseline (EOS/ET), 2-11 years, EQ-5D index score, 4-week interval |
|
|
| Change from Baseline (EOS/ET), 2-11 years, EQ-5D index score, 3-week interval |
|
|
| Change from Baseline (EOS/ET), 12 years and older, EQ-5D index score, 4-week interval |
|
|
| Change from Baseline (EOS/ET), 12 years and older, EQ-5D index score, 3-week interval |
|
|
|
| Baseline (Week 1), 12 years and older, EQ-5D VAS score, 4-week interval |
|
|
| Baseline (Week 1), 12 years and older, EQ-5D VAS score, 3-week interval |
|
|
| Change from Baseline (EOS/ET), 2-11 years, EQ-5D VAS score, 4-week interval |
|
|
| Change from Baseline (EOS/ET), 2-11 years, EQ-5D VAS score, 3-week interval |
|
|
| Change from Baseline (EOS/ET), 12 years and older, EQ-5D VAS score, 4-week interval |
|
|
| Change from Baseline (EOS/ET), 12 years and older, EQ-5D VAS score, 3-week interval |
|
|
|
| 2-13 years, Where do you prefer to receive your immunoglobulin therapy?=At hospital |
|
|
| 2-13 years, Where do you prefer to receive your IG therapy?=At home |
|
|
| 2-13 years, Where do you prefer to receive your IG therapy?=No Preference |
|
|
| 2-13 years, frequency of administration=Like very much |
|
|
| 2-13 years, frequency of administration=Like |
|
|
| 2-13 years, Frequency of administration=No Preference |
|
|
| 2-13 years, number of needlesticks per month=Like very much |
|
|
| 2-13 years, number of needlesticks per month=Like |
|
|
| 2-13 years, number of needlesticks per month=No preference |
|
|
| 2-13 years, total time spent for my treatment per month=Like |
|
|
| 2-13 years, total time spent for my treatment per month=No Preference |
|
|
| 2-13 years, ease of administration= Like |
|
|
| 2-13 years, ease of administration= No Preference |
|
|
| 2-13 years, The ease of administration= Dislike |
|
|
| 2-13 years, potential to self-administer=Like very much |
|
|
| 2-13 years, potential to self-administer=No preference |
|
|
| 2-13 years, potential to self-administer=Dislike |
|
|
| 2-13 years, potential to self-administer=Dislike very much |
|
|
| 2-13 years, ability to fit my treatment into my own schedule= Like |
|
|
| 2-13 years, ability to fit my treatment into my own schedule= No Preference |
|
|
| 2-13 years, overall convenience=Like |
|
|
| 2-13 years, overall convenience=No preference |
|
|
| 2-13 years, amount of time administration takes=Like |
|
|
| 2-13 years, amount of time administration takes=No preference |
|
|
| 2-13 years, amount of time administration takes=Dislike |
|
|
| 2-13 years, complexity of administration process=Like |
|
|
| 2-13 years, complexity of administration process=No preference |
|
|
| 2-13 years, complexity of administration process=Dislike |
|
|
| 2-13 years, My ability to self-administer without medical supervision=Like very much |
|
|
| 2-13 years, My ability to self-administer without medical supervision=No preference |
|
|
| 2-13 years, My ability to self-administer without medical supervision=Dislike |
|
|
| 2-13 years, My ability to self-administer without medical supervision=Dislike very much |
|
|
| 2-13 years, would you choose to continue receiving your treatment using IGg10% with rHuPH20 SC?=Yes |
|
|
| 14 years and older, Before your participation, where did you receive your IG therapy?=At hospital |
|
|
| 14 years and older, Before your participation, where did you receive your IG therapy?=At home |
|
|
| 14 years and older, Before your participation, where did you receive your IG therapy?=Other |
|
|
| 14 years and older, Where do you prefer to receive your IG therapy? = At hospital |
|
|
| 14 years and older, Where do you prefer to receive your IG therapy? = At home |
|
|
| 14 years and older, Where do you prefer to receive your IG therapy? = No preference |
|
|
| 14 years and older, frequency of administration=Like very much |
|
|
| 14 years and older, frequency of administration=Like |
|
|
| 14 years and older, frequency of administration=No preference |
|
|
| 14 years and older, number of needlesticks per month=Like |
|
|
| 14 years and older, number of needlesticks per month=No preference |
|
|
| 14 years and older, total time spent for my treatment per month = Like very much |
|
|
| 14 years and older, total time spent for my treatment per month=Like |
|
|
| 14 years and older, total time spent for my treatment per month=No preference |
|
|
| 14 years and older, total time spent for my treatment per month=Dislike |
|
|
| 14 years and older, ease of administration=Like |
|
|
| 14 years and older, ease of administration=No preference |
|
|
| 14 years and older, ease of administration=Dislike |
|
|
| 14 years and older, ease of administration=Dislike very much |
|
|
| 14 years and older, potential to self-administer=Like |
|
|
| 14 years and older, The potential to self-administer = No preference |
|
|
| 14 years and older, potential to self-administer=Dislike |
|
|
| 14 years and older, potential to self-administer=Dislike very much |
|
|
| 14 years and older, ability to fit my treatment into my own schedule= Like very much |
|
|
| 14 years and older, ability to fit my treatment into my own schedule= Like |
|
|
| 14 years and older, ability to fit my treatment into my own schedule= No preference |
|
|
| 14 years and older, ability to fit my treatment into my own schedule= Dislike |
|
|
| 14 years and older, overall convenience = Like |
|
|
| 14 years and older, overall convenience = No preference |
|
|
| 14 years and older, overall convenience = Dislike |
|
|
| 14 years and older, amount of time administration takes = Like |
|
|
| 14 years and older, amount of time administration takes = No preference |
|
|
| 14 years and older, amount of time administration takes = Dislike |
|
|
| 14 years and older, complexity of administration process=Like very much |
|
|
| 14 years and older, complexity of administration process=Like |
|
|
| 14 years and older, complexity of administration process=No preference |
|
|
| 14 years and older, complexity of administration process=Dislike |
|
|
| 14 years and older, complexity of administration process=Dislike very much |
|
|
| 14 years and older, My ability to self-administer without medical supervision=Like very much |
|
|
| 14 years and older, My ability to self-administer without medical supervision=Like |
|
|
| 14 years and older, My ability to self-administer without medical supervision = No preference |
|
|
| 14 years and older, My ability to self-administer without medical supervision = Dislike |
|
|
| 14 years and older, My ability to self-administer without medical supervision = Dislike very much |
|
|
| 14 years and older, choose to continue receiving your treatment using IGg 10% with rHuPH20 SC?=Yes |
|
|
| 14 years and older, choose to continue receiving your treatment using IGg 10% with rHuPH20 SC?= No |
|
|
|
| Baseline (Week 1), 2-12 years, Convenience, 4-week interval |
|
|
| Baseline (Week 1), 2-12 years, Convenience, 3-week interval |
|
|
| Baseline (Week 1), 2-12 years, Global satisfaction, 4-week interval |
|
|
| Baseline (Week 1), 2-12 years, Global satisfaction, 3-week interval |
|
|
| Baseline (Week 1), 13 years and older, Effectiveness, 4-week interval |
|
|
| Baseline (Week 1), 13 years and older, Effectiveness, 3-week interval |
|
|
| Baseline (Week 1), 13 years and older, Convenience, 4-week interval |
|
|
| Baseline (Week 1), 13 years and older, Convenience, 3-week interval |
|
|
| Baseline (Week 1), 13 years and older, Global satisfaction, 4-week interval |
|
|
| Baseline (Week 1), 13 years and older, Global satisfaction, 3-week interval |
|
|
| Change from Baseline (EOS/ET), 2-12 years, Effectiveness, 4-week interval |
|
|
| Change from Baseline (EOS/ET), 2-12 years, Effectiveness, 3-week interval |
|
|
| Change from Baseline (EOS/ET), 2-12 years, Convenience, 4-week interval |
|
|
| Change from Baseline (EOS/ET), 2-12 years, Convenience, 3-week interval |
|
|
| Change from Baseline (EOS/ET), 2-12 years, Global satisfaction, 4-week interval |
|
|
| Change from Baseline (EOS/ET), 2-12 years, Global satisfaction, 3-week interval |
|
|
| Change from Baseline (EOS/ET), 13 years and older, Effectiveness, 4-week interval |
|
|
| Change from Baseline (EOS/ET), 13 years and older, Effectiveness, 3-week interval |
|
|
| Change from Baseline (EOS/ET), 13 years and older, Convenience, 4-week interval |
|
|
| Change from Baseline (EOS/ET), 13 years and older, Convenience, 3-week interval |
|
|
| Change from Baseline (EOS/ET), 13 years and older, Global satisfaction, 4-week interval |
|
|
| Change from Baseline (EOS/ET), 13 years and older, Global satisfaction, 3-week interval |
|
|