CompletedPhase 3

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

Japan15 participantsStarted 2022-09-13

Plain-language 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.

Who can participate

Age range2 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 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

Timeframe: Up to 3 years

Trial details

NCT IDNCT05513586

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Primary Immunodeficiency Diseases (PID) trials