Drug HypersensitivityNCT05269082
A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults
An observational study of Drug Hypersensitivity, run by Takeda at 1 site in United States.
Trial summary
The aim of this study is to find out whether TAK-880 creates hypersensitivity reactions compared to Gammagard S/D by testing blood taken from participants who have a higher risk of becoming hypersensitive to immunoglobulin products. This study is about collecting data available in the participant's medical record. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Drug Hypersensitivity
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 19 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult participants who are at increased risk of developing hypersensitivity reactions who have been prescribed immunoglobulin treatments according to the investigator's judgment will be included in this study.
Who may be able to join
- At least 2 years of age except PID participants with selective IgA deficiency (the lower age limit in this group of participants is 4 years of age).
- Participant has previously received at least one infusion of Gammagard S/D prescribed for any approved indication (PID, B-cell Chronic Lymphocytic Leukemia, Idiopathic Thrombocytopenic Purpura, Kawasaki Syndrome) OR PID participant with IgA deficiency (serum IgA level of < 7 mg/dL (0.07 g/L) or below the detectable limit in participants older than 4 years) and has received other therapies (prophylactic antibiotics or immunoglobulin treatment other than Gammagard S/D).
- Participant/legally authorized representative is willing to sign an informed consent form or assent form as applicable and is able to comply with the requirements of the protocol.
Who cannot join
- -There are no applicable exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vitro Assessment of Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood From Patients at Increased Risk of Developing Hypersensitivity Reactions
The aim of this study is to find out whether TAK-880 creates hypersensitivity reactions compared to Gammagard S/D by testing blood taken from participants who have a higher risk of becoming hypersensitive to immunoglobulin products.
This study is about collecting data available in the participant's medical record. No study medicines will be provided to participants in this study. Each participant will fill out a study questionnaire during a routine doctor visit. Blood will be taken from participants who have a higher risk of developing hypersensitivity reactions to immunoglobulin products.
- Conditions
- Drug Hypersensitivity
- Being tested
- No intervention
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Pediatric and adult participants who are on Gammagard S/D prescribed for any approved indication will be enrolled in this cohort and evaluated during the observation period (approximately 6 months). Receives: Other: No intervention | |
| Cohort 2 | Pediatric and adult participants who were previously treated with Gammagard S/D prescribed for any approved indication and are on another human immunoglobulin treatment will be enrolled in this cohort and evaluated during the observation period (approximately 6 months). Receives: Other: No intervention | |
| Cohort 3 | Pediatric and adult primary immunodeficiency (PID) participants with immunoglobin A (IgA) deficiency who have a serum IgA level of less than (<) 7 milligrams per deciliter (mg/dL) (0.07 grams/liter [g/L]) or below the detectable limit and have received other therapies (prophylactic antibiotics or immunoglobulin treatment other than Gammagard S/D) will be enrolled in this cohort and evaluated during the observation period (approximately 6 months). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with In Vitro Hypersensitivity to TAK-880 in Comparison to Gammagard S/D
Levels of in vitro hypersensitivity to TAK-880 in comparison to a reference product (Gammagard S/D) using hypersensitivity assays to address (but not limited to) immune cell activation and cytokine secretion, stratified by anti-IgA antibody levels will be evaluated during the study. Number of participants with In vitro hypersensitivity to TAK-880 in comparison to Gammagard S/D will be reported.
Measured: Up to approximately 6 months
Number of Participants with Drug Hypersensitive Reactions to Immunoglobulin Products for Cohort 1 and 2
Number of Participants with drug hypersensitive reactions to immunoglobulin products who have previously received at least one infusion of Gammagard S/D in Cohorts 1 and 2 will be reported.
Measured: Up to approximately 6 months
Number of Participants with History to Drug Hypersensitive Reactions
Number of participants with history to drug hypersensitive reactions will be reported.
Measured: Up to approximately 6 months
Number of Participants Categorized by Clinical Characteristics
Number of participants categorized by clinical characteristics such as geographic location of residency, level of education will be reported.
Measured: Up to approximately 6 months
Number of Participants Categorized by Treatment Patterns
Number of participants categorized by treatment patterns will be reported.
Measured: Up to approximately 6 months
Health Related Quality of Life Measured by 36-Item Short Form Health Survey (SF-36)
SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL). SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning [ranges from 1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]). Four domains comprised physical component summary (PCS) score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised mental component summary (MCS) score (vitality, social functioning, role-emotional, mental health). The total scores range from 0 to 100. Higher scores indicate better quality of life.
Measured: Up to approximately 6 months
Health Related Quality of Life Measured by EuroQol 5 Dimensions Questionnaire (EQ-5D)
EQ-5D is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each participant, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Measured: Up to approximately 6 months
Health Related Quality of Life Measured by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Validated Instrument for Cohort 1 and 2
TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). Scores for each domain are calculated by adding up the items in each domain and then transforming the composite score into a value ranging from 0 to 100. Higher score indicated greater satisfaction in that domain.
Measured: Up to approximately 6 months
Patient Reported Outcomes (PROs) Using PID-Specific Life Quality Index (LQI) Questionnaire for Cohort 1 and 2
The PID-LQI questionnaire involves 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely poor" to 7: "Extremely good". The items measure the impact of the treatment on patient quality of life: factor I (treatment interference), factor II (therapy-related problems), factor III (therapy settings). Results range from 0 (maximal concern) to 100 (no concern). PROs using PID-specific LQI questionnaire in Cohort 1 and 2 will be reported.
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start5 Apr 2022
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269082
- Sponsor's protocol ID
- TAK-880-5001
- Status last verified
- Sep 2022
- First submitted
- 4 Mar 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Assessment of Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood From Patients at Increased Risk of Developing Hypersensitivity Reactions
- ClinicalTrials.gov ID
- NCT05269082
- Acronym / sponsor ID
- TAK-880-5001
- Conditions
- Drug Hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to find out whether TAK-880 creates hypersensitivity reactions compared to Gammagard S/D by testing blood taken from participants who have a higher risk of becoming hypersensitive to immunoglobulin products.
This study is about collecting data available in the participant's medical record. No study medicines will be provided to participants in this study. Each participant will fill out a study questionnaire during a routine doctor visit. Blood will be taken from participants who have a higher risk of developing hypersensitivity reactions to immunoglobulin products.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: No interventionPediatric and adult participants who are on Gammagard S/D prescribed for any approved indication will be enrolled in this cohort and evaluated during the observation period (approximately 6 months). |
| Cohort 2 | – | Other: No interventionPediatric and adult participants who were previously treated with Gammagard S/D prescribed for any approved indication and are on another human immunoglobulin treatment will be enrolled in this cohort and evaluated during the observation period (approximately 6 months). |
| Cohort 3 | – | Other: No interventionPediatric and adult primary immunodeficiency (PID) participants with immunoglobin A (IgA) deficiency who have a serum IgA level of less than (<) 7 milligrams per deciliter (mg/dL) (0.07 grams/liter [g/L]) or below the detectable limit and have received other therapies (prophylactic antibiotics or immunoglobulin treatment other than Gammagard S/D) will be enrolled in this cohort and evaluated during the observation period (approximately 6 months). |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult participants who are at increased risk of developing hypersensitivity reactions who have been prescribed immunoglobulin treatments according to the investigator's judgment will be included in this study.
Key inclusion criteria (3 listed)
- At least 2 years of age except PID participants with selective IgA deficiency (the lower age limit in this group of participants is 4 years of age).
- Participant has previously received at least one infusion of Gammagard S/D prescribed for any approved indication (PID, B-cell Chronic Lymphocytic Leukemia, Idiopathic Thrombocytopenic Purpura, Kawasaki Syndrome) OR PID participant with IgA deficiency (serum IgA level of < 7 mg/dL (0.07 g/L) or below the detectable limit in participants older than 4 years) and has received other therapies (prophylactic antibiotics or immunoglobulin treatment other than Gammagard S/D).
- Participant/legally authorized representative is willing to sign an informed consent form or assent form as applicable and is able to comply with the requirements of the protocol.
Key exclusion criteria (1 listed)
- -There are no applicable exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is a non-interventional study. | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of Participants with In Vitro Hypersensitivity to TAK-880 in Comparison to Gammagard S/D
Time frame: Up to approximately 6 months
Levels of in vitro hypersensitivity to TAK-880 in comparison to a reference product (Gammagard S/D) using hypersensitivity assays to address (but not limited to) immune cell activation and cytokine secretion, stratified by anti-IgA antibody levels will be evaluated during the study. Number of participants with In vitro hypersensitivity to TAK-880 in comparison to Gammagard S/D will be reported.
Number of Participants with Drug Hypersensitive Reactions to Immunoglobulin Products for Cohort 1 and 2
Time frame: Up to approximately 6 months
Number of Participants with drug hypersensitive reactions to immunoglobulin products who have previously received at least one infusion of Gammagard S/D in Cohorts 1 and 2 will be reported.
Number of Participants with History to Drug Hypersensitive Reactions
Time frame: Up to approximately 6 months
Number of participants with history to drug hypersensitive reactions will be reported.
Number of Participants Categorized by Clinical Characteristics
Time frame: Up to approximately 6 months
Number of participants categorized by clinical characteristics such as geographic location of residency, level of education will be reported.
Number of Participants Categorized by Treatment Patterns
Time frame: Up to approximately 6 months
Number of participants categorized by treatment patterns will be reported.
Health Related Quality of Life Measured by 36-Item Short Form Health Survey (SF-36)
Time frame: Up to approximately 6 months
SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL). SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning [ranges from 1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]). Four domains comprised physical component summary (PCS) score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised mental component summary (MCS) score (vitality, social functioning, role-emotional, mental health). The total scores range from 0 to 100. Higher scores indicate better quality of life.
Health Related Quality of Life Measured by EuroQol 5 Dimensions Questionnaire (EQ-5D)
Time frame: Up to approximately 6 months
EQ-5D is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D encompasses 5 domains, asking participants to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each participant, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Health Related Quality of Life Measured by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Validated Instrument for Cohort 1 and 2
Time frame: Up to approximately 6 months
TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). Scores for each domain are calculated by adding up the items in each domain and then transforming the composite score into a value ranging from 0 to 100. Higher score indicated greater satisfaction in that domain.
Patient Reported Outcomes (PROs) Using PID-Specific Life Quality Index (LQI) Questionnaire for Cohort 1 and 2
Time frame: Up to approximately 6 months
The PID-LQI questionnaire involves 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely poor" to 7: "Extremely good". The items measure the impact of the treatment on patient quality of life: factor I (treatment interference), factor II (therapy-related problems), factor III (therapy settings). Results range from 0 (maximal concern) to 100 (no concern). PROs using PID-specific LQI questionnaire in Cohort 1 and 2 will be reported.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Hypersensitivity, run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with In Vitro Hypersensitivity to TAK-880 in Comparison to Gammagard S/D (time frame: Up to approximately 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022; AzTrials last refreshed its copy on 30 Oct 2026.