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

Phase 3

Active, not recruiting

• Conditions: Primary Immunodeficiency Diseases (PID)
• Interventions: Drug: TAK-771

• Registration Number: NCT05513586
• Lead Sponsor: Takeda

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-24
• Study Start: 2022-09-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAK-771	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)	Up to 3 years	TEAEs are defined as AEs with onset after date-time of first dose of investigational drug or medical conditions present prior to the start of investigational drug but increased in severity or relationship after date-time of first dose of investigational drug.
Percentage of Participants who Develop Anti-rHuPH20 Binding Antibody Titers of Greater Than or Equal to 1:160 and who Develop Neutralizing Antibodies to rHuPH20	Up to 3 years

Trial Locations

Locations (9)

Kyushu University Hospital; 🇯🇵 Fukuoka, Japan

Nagoya University Hospital; 🇯🇵 Nagoya, Aichi, Japan

Kanagawa Children's Medical Center; 🇯🇵 Yokohama, Kanagawa, Japan

Tokyo Medical Dental University Hospital; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Gifu University Hospital; 🇯🇵 Gifu, Japan

Saitama Prefectual Children's Medical Center; 🇯🇵 Saitama, Japan

Shizuoka Childrens Hospital; 🇯🇵 Shizuoka, Japan

Hospital of University of Occupational and Environmental Health; 🇯🇵 Kitakyushu, Fukuoka, Japan

Hiroshima University Hospital; 🇯🇵 Hiroshima, Japan