NCT06565078 A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
| NCT ID | NCT06565078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Takeda |
| Condition | Primary Immunodeficiency Diseases (PID) |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2030-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-02-17 with a primary completion date of 2030-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2.
Eligibility Criteria
Inclusion Criteria: 1. Patients with primary immunodeficiency (PID) enrolled in the PID patient registry. 2. Participant for whom study drug is entered in the therapeutic drug field on the data set. 3. Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field. 4. Participant for whom the presence or absence of adverse events has been entered in the column of adverse events. Exclusion Criteria: 1. Participant for whom study drug has not been entered in the drug name in the medical history field during the period from January 24, 2024 to January 23, 2029. 2. Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field. 3. Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06565078 clinical trial?
This trial is open to participants of all sexes, studying Primary Immunodeficiency Diseases (PID). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06565078 currently recruiting?
Yes, NCT06565078 is actively recruiting participants. Contact the research team at medinfoUS@takeda.com for enrollment information.
Where is the NCT06565078 trial being conducted?
This trial is being conducted at Tokyo, Japan.
Who is sponsoring the NCT06565078 clinical trial?
NCT06565078 is sponsored by Takeda. The trial plans to enroll 100 participants.