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

Primary Immunodeficiency Diseases (PID) Clinical Trial

Official title:

A Phase 3, Open-label, Non-controlled, Extension Study to Evaluate the Long-term Safety of TAK-771 in Japanese Patients With Primary Immunodeficiency Disease (PID)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05513586
• Other study ID #: TAK-771-3005
• Secondary ID: jRCT2041220059
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 13, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immunodeficiency Diseases
• Primary Immunodeficiency Diseases (PID)

Intervention

Drug:
• TAK-771
Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)

Locations

Country	Name	City	State
Japan	Tokyo Medical Dental University Hospital	Bunkyo-ku	Tokyo
Japan	Kyushu University Hospital	Fukuoka
Japan	Gifu University Hospital	Gifu
Japan	Hiroshima University Hospital	Hiroshima
Japan	Hospital of University of Occupational and Environmental Health	Kitakyushu	Fukuoka
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Saitama Prefectual Children's Medical Center	Saitama
Japan	Shizuoka Childrens Hospital	Shizuoka
Japan	Kanagawa Children's Medical Center	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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