Evaluating the safety of a 20% Immune Globulin solution in patients with primary immunodeficiency
Post-marketing Database Survey: A Cohort Study to Evaluate the Safety of Cuvitru in Patients With Primary Immunodeficiency Using the PIDJ2 (Primary Immunodeficiency Database in Japan) Registry
This study is trying to see if a 20% immune globulin solution is safe for people with primary immunodeficiency diseases by looking at past patient data from Japan.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (Tokyo, Tokyo) |
| Trial ID | NCT06565078 on ClinicalTrials.gov |
What this trial studies
This observational study conducts a retrospective database survey in Japan to assess the safety of Immune Globulin Subcutaneous (Human), 20% Solution in individuals diagnosed with primary immunodeficiency diseases (PID). Utilizing the PIDJ2 medical database, the study will analyze data from patients enrolled in a PID patient registry, focusing on the presence or absence of adverse events related to the treatment. The study aims to provide insights into the safety profile of this therapeutic intervention over a specified period.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a confirmed diagnosis of primary immunodeficiency who are registered in the PID patient registry.
Not a fit: Patients who do not have a diagnosis of primary immunodeficiency or who have not received the study drug will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the safety of Immune Globulin therapy, potentially leading to improved treatment protocols for patients with primary immunodeficiency.
How similar studies have performed: While this study is observational and retrospective, similar studies evaluating the safety of immune globulin therapies have shown promising results in the past.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tokyo, Tokyo
- Takeda selected site — Tokyo, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.