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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1265-9447 | Other Identifier | WHO | |
| jRCT2041210006 | Registry Identifier | jRCT |
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This study is an extension study for participants with primary immunodeficiency disorders who were previously treated with IGSC, 20% in the TAK-664-3001 study. They must have completed that study or be about to complete it before joining this study. Participants will continue treatment with IGCS, 20% in this study.
The main aim of this study is to check for side effects from long-term treatment with IGSC, 20% . This medicine is not yet licensed in Japan, so participants will be treated with IGSC, 20% until it becomes commercially available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGSC, 20% | Experimental | Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of Immune globulin subcutaneous (IGSC) infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGSC 20% infusion | Biological | IGSC 20% infusion, |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs | TEAEs were defined as adverse events (AEs) with onset after date-time of first dose of study drug (intravenous immunoglobulin [IGIV] or IGSC), or medical conditions present prior to the start of study drug (IGIV or IGSC) but increased in severity or relationship after date-time of first dose of study drug (IGIV or IGSC). A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
| Number of Participants With Drug-related and Non-related TEAEs | TEAEs were defined as adverse events (AEs) with onset after date-time of first dose of study drug (intravenous immunoglobulin [IGIV] or IGSC), or medical conditions present prior to the start of study drug (IGIV or IGSC) but increased in severity or relationship after date-time of first dose of study drug (IGIV or IGSC). Any TEAE that was recorded by the investigator as "probably related" or "possibly related" to study drug was considered as study drug related AE, and any AE recorded as "unlikely related" or "not related" was considered as unrelated AE. | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
| Number of Participants With Severe, Local and Systemic TEAEs | A severe TEAE was an AE that caused considerable interference with the participant's usual activities. Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infusion site". Systemic TEAEs were defined as AEs that were not included in the Medical Dictionary for Regulatory Activities (MedDRA) Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site" or "infusion site". | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Trough Levels of Total Immune Globulin G (IgG) and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Weekly Administration of IGSC, 20% | Serum trough levels of total IgG and IgG1, IgG2, IgG3, IgG4 antibodies subclasses were determined by using standard assay methods. | At end of treatment in the current extension study TAK-664-3002 (i.e. 3 years) |
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Inclusion Criteria:
Participant has completed or is about to complete Takeda Clinical Study TAK-664-3001.
A participant is considered to have completed Study TAK-664-3001 successfully if they fulfill the following criterion: Completed Epoch 2, in which IGSC, 20% is administered weekly (completion of Epoch 3, in which IGSC, 20% is administered biweekly, is not mandatory for participation in TAK-664-3002 study).
Written informed consent is obtained from either the Participant or the Participant's legally authorized representative prior to any study-related procedures and study product administration.
Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
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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 | |||
| Kurume University Hospital |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).
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Participants with primary immunodeficiency disorders who completed core study TAK-664-3001 (NCT04346108) were enrolled to receive Immune globulin subcutaneous (IGCS), 20 percent (%) in this current extension study (TAK-664-3002 [NCT04842643]). As per planned analysis, the data was collected, analyzed and reported for a single arm only and per dose level wise data was not collected in this study.
Participants took part in the study at 8 investigative sites in Japan from 27 April 2021 to 25 April 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | IGSC, 20% | Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | IGSC, 20% | Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs | TEAEs were defined as adverse events (AEs) with onset after date-time of first dose of study drug (intravenous immunoglobulin [IGIV] or IGSC), or medical conditions present prior to the start of study drug (IGIV or IGSC) but increased in severity or relationship after date-time of first dose of study drug (IGIV or IGSC). A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. | All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study. | Posted | Count of Participants | Participants | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
|
From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose
As per planned analysis, the data for this AE section was collected, analyzed and reported for a single arm only and per dose level wise data was not collected. All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study.
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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 | IGSC, 20% | Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.0 | 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 | Nov 28, 2022 | Oct 18, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2023 | Oct 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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| Number of Participants With TEAEs Leading to Premature Discontinuation From Study and Infusion-associated TEAEs | Infusion associated TEAEs were defined as any TEAE that began during study drug infusion or within 72 hours of completion of study drug infusion. TEAEs leading to premature discontinuation from study and infusion-associated TEAEs were reported. | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
| Serum Trough Levels of IgG and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Biweekly Administration of IGSC, 20% | Serum trough levels of IgG and IgG1, IgG2, IgG3, IgG4 antibodies subclasses were determined by using standard assay methods. | At end of treatment in the current extension study TAK-664-3002 (i.e. 3 years) |
| Annual Rate of Validated Acute Serious Bacterial Infections (ASBI) | The ASBI rate was calculated as the mean number of acute serious bacterial infections per participants per year. Annual rate of validated acute serious bacterial infections per participant was assessed. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
| Annual Rate of All Infections | The annual rate of infections was calculated as the mean number of infections per participant per year. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
| Number of Days Participants Not Able to Attend School or Work to Perform Normal Daily Activities Due to Illness/Infection | Number of days not able to attend school or work to perform normal daily activities due to illness/infection are standardized per year (365.25 days). Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
| Number of Days Participants on Antibiotics | Number of days on antibiotics was defined as the number of days those antibiotics were taken as concomitant medications and was standardized to per year (365.25 days). Number of days participants on antibiotics were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
| Number of Hospitalizations Due to Illness or Infection | Number of hospitalizations were standardized to per year (365.25 days). Hospitalizations were measured by asking participants to report the number of nights they have stayed overnight in the hospital during the year, for something related to their own health. Number of hospitalizations due to illness or infection were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
| Length of Hospital Stay Due to Illness or Infection | Length of hospital stay per stay was standardized to per year (365.25 days). Number of days due to illness or infection were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
| Number of Acute Physician Visits Due to Illness/Infection | Number of acute physician visits is standardized to per year (365.25 days). Number of acute (urgent or unscheduled) physician visits due to illness/infection were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
| Number of Participants With Their Response for Treatment Preference Questionnaire | Treatment preference questionnaire is a self-administered questionnaire developed to assess participant's preference towards the administration of new IGSC therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the IGSC treatment. For First question "Before participation in the trial(s), where did you receive your immunoglobulin therapy" participants were allowed to select multiple answers for options ("At the hospital"; "At home"; "Other") for their treatment. As a result, the sum of responders in the arm "IGSC, 20%: >=14 Years" for the first question were higher than the total number of participants analyzed in the category. | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
| Number of Participants With Tolerability Events Related to the Infusion of Study Drug | An infusion was considered tolerable if the infusion rate was not reduced, or the infusion was not interrupted or stopped, due to a TEAE related to study drug infusion. A tolerability event was considered to have occurred if an infusion was not tolerable. | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
| Kurume |
| Fukuoka |
| Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | Japan |
| National defense medical college Hospital | Tokorozawa | Saitama | Japan |
| Kyushu University Hospital | Fukuoka | Japan |
| Gifu University Hospital | Gifu | Japan |
| Hiroshima University Hospital | Hiroshima | Japan |
| Tokyo Medical Dental University Hospital | Tokyo | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| IGSC, 20% |
Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of IGSC infusion, 20% infusion once a week (Epoch 2 regimen) and 100 to 400 mg/kg of IGSC infusion, 20% biweekly (Epoch 3 regimen) until the study drug becomes commercially available. |
|
|
| Primary | Number of Participants With Drug-related and Non-related TEAEs | TEAEs were defined as adverse events (AEs) with onset after date-time of first dose of study drug (intravenous immunoglobulin [IGIV] or IGSC), or medical conditions present prior to the start of study drug (IGIV or IGSC) but increased in severity or relationship after date-time of first dose of study drug (IGIV or IGSC). Any TEAE that was recorded by the investigator as "probably related" or "possibly related" to study drug was considered as study drug related AE, and any AE recorded as "unlikely related" or "not related" was considered as unrelated AE. | All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study. | Posted | Count of Participants | Participants | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
|
|
|
| Primary | Number of Participants With Severe, Local and Systemic TEAEs | A severe TEAE was an AE that caused considerable interference with the participant's usual activities. Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase "injection site" or "infusion site". Systemic TEAEs were defined as AEs that were not included in the Medical Dictionary for Regulatory Activities (MedDRA) Higher Level Group Term "administration site reactions" and did not contain the phrase "injection site" or "infusion site". | All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study. | Posted | Count of Participants | Participants | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
|
|
|
| Primary | Number of Participants With TEAEs Leading to Premature Discontinuation From Study and Infusion-associated TEAEs | Infusion associated TEAEs were defined as any TEAE that began during study drug infusion or within 72 hours of completion of study drug infusion. TEAEs leading to premature discontinuation from study and infusion-associated TEAEs were reported. | All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study. | Posted | Count of Participants | Participants | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
|
|
|
| Secondary | Serum Trough Levels of Total Immune Globulin G (IgG) and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Weekly Administration of IGSC, 20% | Serum trough levels of total IgG and IgG1, IgG2, IgG3, IgG4 antibodies subclasses were determined by using standard assay methods. | All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study. Here" overall number of participants analyzed" signified participants who were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | grams per liter (g/L) | At end of treatment in the current extension study TAK-664-3002 (i.e. 3 years) |
|
|
|
| Secondary | Serum Trough Levels of IgG and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Biweekly Administration of IGSC, 20% | Serum trough levels of IgG and IgG1, IgG2, IgG3, IgG4 antibodies subclasses were determined by using standard assay methods. | All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study. Here" overall number of participants analyzed" signified participants who were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | g/L | At end of treatment in the current extension study TAK-664-3002 (i.e. 3 years) |
|
|
|
| Secondary | Annual Rate of Validated Acute Serious Bacterial Infections (ASBI) | The ASBI rate was calculated as the mean number of acute serious bacterial infections per participants per year. Annual rate of validated acute serious bacterial infections per participant was assessed. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001. | Posted | Mean | Standard Deviation | infections per year | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
|
|
|
| Secondary | Annual Rate of All Infections | The annual rate of infections was calculated as the mean number of infections per participant per year. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001. | Posted | Mean | Standard Deviation | infections per year | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
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|
|
| Secondary | Number of Days Participants Not Able to Attend School or Work to Perform Normal Daily Activities Due to Illness/Infection | Number of days not able to attend school or work to perform normal daily activities due to illness/infection are standardized per year (365.25 days). Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001. | Posted | Median | Full Range | days | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
|
|
|
| Secondary | Number of Days Participants on Antibiotics | Number of days on antibiotics was defined as the number of days those antibiotics were taken as concomitant medications and was standardized to per year (365.25 days). Number of days participants on antibiotics were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001. | Posted | Median | Full Range | days | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
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|
|
| Secondary | Number of Hospitalizations Due to Illness or Infection | Number of hospitalizations were standardized to per year (365.25 days). Hospitalizations were measured by asking participants to report the number of nights they have stayed overnight in the hospital during the year, for something related to their own health. Number of hospitalizations due to illness or infection were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001. | Posted | Mean | Standard Deviation | hospitalization | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
|
|
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| Secondary | Length of Hospital Stay Due to Illness or Infection | Length of hospital stay per stay was standardized to per year (365.25 days). Number of days due to illness or infection were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001. Here" overall number of participants analyzed" signified participants who were evaluable for this outcome measure. | Posted | Median | Full Range | days | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
|
|
|
| Secondary | Number of Acute Physician Visits Due to Illness/Infection | Number of acute physician visits is standardized to per year (365.25 days). Number of acute (urgent or unscheduled) physician visits due to illness/infection were reported. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. | The Core Study All-Treated Set consisted of participants who received at least 1 dose of study drug (IGIV or IGSC) in TAK-664-3001. | Posted | Mean | Standard Deviation | visits per year | From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) |
|
|
|
| Secondary | Number of Participants With Their Response for Treatment Preference Questionnaire | Treatment preference questionnaire is a self-administered questionnaire developed to assess participant's preference towards the administration of new IGSC therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the IGSC treatment. For First question "Before participation in the trial(s), where did you receive your immunoglobulin therapy" participants were allowed to select multiple answers for options ("At the hospital"; "At home"; "Other") for their treatment. As a result, the sum of responders in the arm "IGSC, 20%: >=14 Years" for the first question were higher than the total number of participants analyzed in the category. | All-Treated Set consisted of all enrolled participants who received IGSC, 20% administration at least once in this study. As pre-specified in protocol, data was planned to be reported as per age criteria (2-13 years and >=14 years) for this outcome measure. | Posted | Count of Participants | Participants | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
|
|
|
| Secondary | Number of Participants With Tolerability Events Related to the Infusion of Study Drug | An infusion was considered tolerable if the infusion rate was not reduced, or the infusion was not interrupted or stopped, due to a TEAE related to study drug infusion. A tolerability event was considered to have occurred if an infusion was not tolerable. | The Safety Analysis Set (SAS) consisted of all participants who received at least 1 dose of study drug (IGIV or IGSC). | Posted | Count of Participants | Participants | From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose |
|
|
|
| 0 |
| 12 |
| 3 |
| 12 |
| 12 |
| 12 |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Administration site discolouration | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chorioretinopathy | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cutaneous amyloidosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Infusion site bruising | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Infusion site pruritus | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Infusion site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nodal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Occult blood positive | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Orthostatic intolerance | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Post-acute COVID-19 syndrome | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Puncture site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Retrograde amnesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tooth resorption | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Vaccination site joint erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vaccination site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
Not provided
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| IgG 4 |
|
| IgG Total |
|
| Title | Measurements |
|---|---|
|
| IgG 4 |
|
| IgG Total |
|
| Before participation in trial(s), where did you receive your immunoglobulin therapy: At hospital |
|
|
| Before participation in the trial(s), where did you receive your immunoglobulin therapy: Other |
|
|
| Where do you Prefer to Receive Your Immunoglobulin Therapy: At Hospital |
|
|
| Where do you Prefer to Receive Your Immunoglobulin Therapy: At Home |
|
|
| Where do you Prefer to Receive Your Immunoglobulin Therapy: No Preference |
|
|
| The Frequency of Administration: Like very much |
|
|
| The Frequency of Administration: Like |
|
|
| The Frequency of Administration: No preference |
|
|
| The Frequency of Administration: Dislike |
|
|
| The Frequency of Administration: Dislike very much |
|
|
| The number of needlesticks per month: Like very much |
|
|
| The number of needlesticks per month: Like |
|
|
| The number of needlesticks per month: No preference |
|
|
| The number of needlesticks per month: Dislike |
|
|
| The number of needlesticks per month: Dislike very much |
|
|
| Total time spent for treatment per month: Like very much |
|
|
| Total time spent for treatment per month: Like |
|
|
| Total time spent for treatment per month: No preference |
|
|
| Total time spent for treatment per month: Dislike |
|
|
| Total time spent for treatment per month: Dislike very much |
|
|
| The ease of administration: Like very much |
|
|
| The ease of administration: Like |
|
|
| The ease of administration: No preference |
|
|
| The ease of administration: Dislike |
|
|
| The ease of administration: Dislike very much |
|
|
| The potential to self-administer: Like very much |
|
|
| The potential to self-administer: Like |
|
|
| The potential to self-administer: No preference |
|
|
| The potential to self-administer: Dislike |
|
|
| The potential to self-administer: Dislike very much |
|
|
| Ability to fit treatment into schedule: Like very much |
|
|
| Ability to fit treatment into schedule: Like |
|
|
| Ability to fit treatment into schedule: No preference |
|
|
| Ability to fit treatment into schedule: Dislike |
|
|
| Ability to fit treatment into schedule: Dislike very much |
|
|
| The overall convenience: Like very much |
|
|
| The overall convenience: Like |
|
|
| The overall convenience: No preference |
|
|
| The overall convenience: Dislike |
|
|
| The overall convenience: Dislike very much |
|
|
| The amount of time administration takes: Like very much |
|
|
| The amount of time administration takes: Like |
|
|
| The amount of time administration takes: No preference |
|
|
| The amount of time administration takes: Dislike |
|
|
| The amount of time administration takes: Dislike very much |
|
|
| Complexity of administration: Like very much |
|
|
| Complexity of administration process: Like |
|
|
| Complexity of administration: No preference |
|
|
| Complexity of administration: Dislike |
|
|
| Complexity of administration: Dislike very much |
|
|
| Ability to self-administer: Like very much |
|
|
| Ability to self-administer: Like |
|
|
| Ability to self-administer: No preference |
|
|
| Ability to self-administer: Dislike very much |
|
|
| Ability to self-administer: Dislike |
|
|
| Choose to continue receiving IGSC: Yes |
|
|
| Choose to continue receiving IGSC: No |
|
|
| Factor influence decision: Two way needle, to see more variation in volume of chemical solution. |
|
|
| Factor influenced decision: Can be self-administered at home |
|
|
| Factor influenced decision: Easy administration method, easy to use |
|
|
| Factor influenced decision: Feel relieved |
|
|
| Factor influenced decision: Fewer side effects. IgG levels stabilized and became easier |
|
|
| Factor influence decision:.Take time to prepare, clean up, for area affected by needle to recover. |
|
|
| Factor influenced decision: Less susceptible to infections. Atopic dermatitis improved |
|
|
| Factor influenced decision: No answer |
|
|
| Factor influenced decision: No more coughing |
|
|
| Factor influenced decision: The values are stable |
|
|
| Factor influenced decision: Time is short |
|
|
| Factor influence decision: There were no major side effects and stable medical condition |
|
|
| Title | Measurements |
|---|---|
|