MedPath

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

Phase 3
Conditions
Primary Immunodeficiency Diseases (PID)
Registration Number
JPRN-jRCT2041220059
Lead Sponsor
ishizawa Atsushi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
15
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:
a. Participant presents with a positive pregnancy test.
b. 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath