Clinical trial NCT05269082: A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Hypersensitivity
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-03-07
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

-There are no applicable exclusion criteria for this study.

Primary outcomes:
measure: Number of Participants with In Vitro Hypersensitivity to TAK-880 in Comparison to Gammagard S/D
timeFrame: Up to approximately 6 months
measure: Number of Participants with Drug Hypersensitive Reactions to Immunoglobulin Products for Cohort 1 and 2
timeFrame: Up to approximately 6 months
measure: Number of Participants with History to Drug Hypersensitive Reactions
timeFrame: Up to approximately 6 months
measure: Number of Participants Categorized by Clinical Characteristics
timeFrame: Up to approximately 6 months
measure: Number of Participants Categorized by Treatment Patterns
timeFrame: Up to approximately 6 months
measure: Health Related Quality of Life Measured by 36-Item Short Form Health Survey (SF-36)
timeFrame: Up to approximately 6 months
measure: Health Related Quality of Life Measured by EuroQol 5 Dimensions Questionnaire (EQ-5D)
timeFrame: Up to approximately 6 months
measure: Health Related Quality of Life Measured by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) Validated Instrument for Cohort 1 and 2
timeFrame: Up to approximately 6 months
measure: Patient Reported Outcomes (PROs) Using PID-Specific Life Quality Index (LQI) Questionnaire for Cohort 1 and 2
timeFrame: Up to approximately 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: PPD
state: North Carolina
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: