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NCT06076642 · ClinicalTrials.gov registry record · Phase 3
A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases
A Phase 3 study of Primary Immunodeficiency Diseases (PID), sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 39
- Enrollment target
- 5
- Study locations
NCT06076642: Recruiting Phase 3 study of Primary Immunodeficiency Diseases (PID), sponsored by Takeda.
NCT06076642 is a Phase 3 study of Primary Immunodeficiency Diseases (PID) that is actively recruiting participants, run by Takeda. The registered enrollment target is 39 participants, below the 110-participant average among 3 other Primary Immunodeficiency Diseases (PID) trials with a reported enrollment target (65% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06076642, a Phase 3 study of Primary Immunodeficiency Diseases (PID), is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 39 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL TAK-881
- DEVICE SC Investigational Needle Sets
Study Locations (5)
Georgia
- Central Georgia Infectious Disease Consultants - Macon
Illinois
- Sneeze, Wheeze, & Itch Associates, LLC - Normal
New York
- Montefiore Medical Center - The Bronx
North Carolina
- Duke Asthma, Allergy and Airway Center - Durham
Texas
- Allergy Partners of North Texas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2024-11-04 |
| Est. Completion | 2029-01-15 |
| Phase | Phase 3 |
What NCT06076642 shows while recruiting
NCT06076642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 110-participant average among 3 other Primary Immunodeficiency Diseases (PID) trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Primary Immunodeficiency Diseases (PID) appearing as the primary indexed condition, and to 2 interventions - of which TAK-881 is the first listed.
NCT06076642 lists 5 locations in 5 states (Georgia, Illinois, New York).
Frequently Asked Questions
What is clinical trial NCT06076642 about?
NCT06076642 is a clinical study titled "A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases". 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 dosag...
What is the current status of trial NCT06076642?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2024-11-04. Estimated completion is 2029-01-15.
What conditions does trial NCT06076642 study?
This clinical trial studies the following conditions: Primary Immunodeficiency Diseases (PID).
What interventions are being tested in trial NCT06076642?
The interventions under investigation include: TAK-881 (BIOLOGICAL), SC Investigational Needle Sets (DEVICE).
Who is sponsoring clinical trial NCT06076642?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06076642 being conducted?
This trial has 5 study locations across Georgia, Illinois, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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