A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2025-10-31

Brief Summary

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The main aim of the study is to check side effect from the study treatment with TAK-771 in long term.

Participants can have taken part in the previous study TAK-771-3004 (NCT05150340). For those who can take part, the participants will receive injections of TAK-771 after the end of the previous study. The participants will be treated with TAK-771 for totally 3 years.

There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug.

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Detailed Description

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Conditions

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Primary Immunodeficiency Diseases (PID)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAK-771

TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC 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.

Group Type EXPERIMENTAL

TAK-771

Intervention Type DRUG

Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)

Interventions

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TAK-771

Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)

Intervention Type DRUG

Other Intervention Names

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Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Eligibility Criteria

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Inclusion Criteria

1. Participant have completed or is about to complete Study TAK-771-3004 (NCT05150340).
2. Written and/or electronic 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. If a participant is \<18 years of age, written and/or electronic informed consent should also be obtained from the participant's legally authorized representative in addition to written informed assent by a participant if appropriate.
3. Participant is willing and able to comply with the requirements of the protocol.

Exclusion Criteria

1. Participant has developed a new serious medical condition during Study TAK-771-3004 such that the participant's safety or medical care would be impacted by participation in the study.
2. Participant is willing to participate in other clinical trials.
3. Women of childbearing potential who meet any one of the following criteria:

1. Participant presents with a positive pregnancy test.
2. Participant does not agree to employ adequate birth-control measures (eg, intrauterine device, condom \[for male partner\], or birth-control pills) throughout the course of the study.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No