drugset / Trial / NCT06076642
A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases
Phase 3
Active not recruiting
53 enrolled
Takeda
Baxalta Innovations GmbH, now part of Takeda · collabTakeda Development Center Americas, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-11-04
- Primary completion
- 2028-05-16
- Completion
- 2028-05-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | — | Subcutaneous |