drugset / Trial / NCT03277313
Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects
Phase 3
Completed
44 enrolled
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire · collab
Non-randomizedSingle-groupOpen-labelPrevention
Summary
The purpose of the study is to acquire additional data on efficacy, safety, tolerability, immunogenicity, pharmacokinetic (PK) and other parameters of HYQVIA in pediatric (age ≥ 2 to \<16 years) participants with primary immunodeficiency disease (PIDD).
Timeline
- Start
- 2017-09-25
- Primary completion
- 2022-07-20
- Completion
- 2022-07-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Infusion 10% (Human) | Protein / enzyme biologic | — | Subcutaneous |
| Background | rHuPH20 | Protein / enzyme biologic | — | Subcutaneous |