A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults

Takeda

Status: Completed

Conditions: Drug Hypersensitivity

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05269082

TAK-880-5001

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

72 participants in 3 patient groups

Cohort 1

Description:

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).

Treatment:

Other: No intervention

Cohort 2

Description:

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).

Treatment:

Other: No intervention

Cohort 3

Description:

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).

Treatment:

Other: No intervention