A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease … (NCT05513586) | Clinical Trial Compass
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 range
2 Years
Sex
ALL
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 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From start of study drug administration up to end of study (up to 3.1 years)
2
Percentage of Participants Who Developed Anti-rHuPH20 Binding Antibody Titers of >=1:160 and Neutralizing Antibodies to rHuPH20
Timeframe: From start of study drug administration up to end of study (up to 3.1 years)
. 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.