CompletedPhase 3

An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease

Japan12 participantsStarted 2021-04-27

Plain-language summary

This study is an extension study for participants with primary immunodeficiency disorders who were previously treated with IGSC, 20% in the TAK-664-3001 study. They must have completed that study or be about to complete it before joining this study. Participants will continue treatment with IGCS, 20% in this study. The main aim of this study is to check for side effects from long-term treatment with IGSC, 20% . This medicine is not yet licensed in Japan, so participants will be treated with IGSC, 20% until it becomes commercially available.

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant has completed or is about to complete Takeda Clinical Study TAK-664-3001.
✓. Written 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.
✓. Participant is willing and able to comply with the requirements of the protocol.

Exclusion criteria

✕. Participant has developed a new serious medical condition during participation in Study TAK-664-3001 such that the Participant's safety or medical care would be impacted by participation in the extension study TAK-664-3002.
✕. Participant is scheduled to participate in another non-Takeda clinical study involving an Investigational Product or device-used-in-clinical-trial in the course of this study.
✕. If a female of childbearing potential, Participant is pregnant or has a negative pregnancy test but does not agree to employ adequate birth control measures for the duration of the study.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs

Timeframe: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose

Number of Participants With Drug-related and Non-related TEAEs

Timeframe: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose

Number of Participants With Severe, Local and Systemic TEAEs

Timeframe: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose

Number of Participants With TEAEs Leading to Premature Discontinuation From Study and Infusion-associated TEAEs

Timeframe: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose

Trial details

NCT IDNCT04842643

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-25

Results submitted2024-10-18

View on ClinicalTrials.gov More Primary Immunodeficiency Disease trials

Plain-language summary

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant has completed or is about to complete Takeda Clinical Study TAK-664-3001.
✓. Written 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.
✓. Participant is willing and able to comply with the requirements of the protocol.

Exclusion criteria

✕. Participant has developed a new serious medical condition during participation in Study TAK-664-3001 such that the Participant's safety or medical care would be impacted by participation in the extension study TAK-664-3002.
✕. Participant is scheduled to participate in another non-Takeda clinical study involving an Investigational Product or device-used-in-clinical-trial in the course of this study.
✕. If a female of childbearing potential, Participant is pregnant or has a negative pregnancy test but does not agree to employ adequate birth control measures for the duration of the study.