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

NCT05513586 | Completed Phase 3

• 2 other identifiers: TAK-771-3005jRCT2041220059
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 9

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.

Conditions

Primary Immunodeficiency Diseases (PID)

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)

  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.

  Up to 3 years

• 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

Study Arms (1)

TAK-771

EXPERIMENTAL

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.

Drug: TAK-771

Interventions

TAK-771 DRUG

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

Also known as: Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

TAK-771

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant have completed or is about to complete Study TAK-771-3004 (NCT05150340).
• 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.
• Participant is willing and able to comply with the requirements of the protocol.

You may not qualify if:

• 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.
• Participant is willing to participate in other clinical trials.
• Women of childbearing potential who meet any one of the following criteria:
• Participant presents with a positive pregnancy test.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (9)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Location

Hospital of University of Occupational and Environmental Health

Kitakyushu, Fukuoka, Japan

Location

Gifu University Hospital

Gifu, Gifu, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Location

Kanagawa Children's Medical Center

Yokohama, Kanagawa, Japan

Location

Saitama Prefectual Children's Medical Center

Saitama, Saitama, Japan

Location

Shizuoka Childrens Hospital

Shizuoka, Shizuoka, Japan

Location

Tokyo Medical Dental University Hospital

Bunkyo-ku, Tokyo, Japan

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: September 13, 2022
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (9)