A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases
Public ClinicalTrials.gov record NCT06076642. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Long-term Safety and Tolerability of TAK-881 in Subjects With Primary Immunodeficiency Diseases (PIDD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035). The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035). After the first TAK-881 infusion in study TAK-881-3002, the dosing interval (can be adjusted by participant/caregiver) and/or the dose of TAK-881 can be adjusted by the study doctor to every 2, 3 or 4 weeks at scheduled site visits. Participants will visit the clinic every 12 weeks until the End of Study (EOS) visit.
Study identification
- NCT ID
- NCT06076642
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 53 participants
Conditions and interventions
Conditions
Interventions
- TAK-881 Biological
- Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US) Device
Biological · Device
Eligibility (public fields only)
- Age range
- 2 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 3, 2024
- Primary completion
- May 15, 2028
- Completion
- May 15, 2028
- Last update posted
- Apr 7, 2026
2024 – 2028
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Irvine Medical Sciences I | Irvine | California | 92697 | — |
| Allergy & Asthma Clinical Research | Walnut Creek | California | 94598 | — |
| National Jewish Medical And Research Center | Denver | Colorado | 80206-2761 | — |
| University of South Florida | St. Petersburg | Florida | 33701 | — |
| Central Georgia Infectious Disease Consultants | Macon | Georgia | 31201 | — |
| Rush University Medical Center-Allergy/ Immunology Center | Chicago | Illinois | 60612-3852 | — |
| Sneeze, Wheeze, & Itch Associates, LLC | Normal | Illinois | 61761 | — |
| Louisiana State University Health Science Center | New Orleans | Louisiana | 70118 | — |
| North Shore-Long Island Jewish Health Systems | Great Neck | New York | 11021 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Duke Asthma, Allergy and Airway Center | Durham | North Carolina | 27705 | — |
| Allergy, Asthma and Immunology Center | Tulsa | Oklahoma | 74136 | — |
| Allergy Partners of North Texas | Dallas | Texas | 75230 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06076642, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 7, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06076642 live on ClinicalTrials.gov.