Trials / Completed
CompletedNCT03116347
Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects With Primary Immunodeficiency Diseases
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to acquire additional data on safety, tolerability and immunogenicity of HyQvia in pediatric (age two to \<18 years) patients with Primary Immunodeficiency Diseases (PIDD)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HYQVIA | Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (IGI, 10% with rHuPH20) |
| BIOLOGICAL | KIOVIG | 100 mg/ml solution for Immune Globulin Intravenous Infusion |
| BIOLOGICAL | Cuvitru | 200 mg/ml solution for Immune Globulin Subcutaneous Injection |
Timeline
- Start date
- 2017-05-30
- Primary completion
- 2021-01-15
- Completion
- 2021-01-15
- First posted
- 2017-04-17
- Last updated
- 2023-01-11
- Results posted
- 2023-01-11
Locations
20 sites across 8 countries: Czechia, Denmark, France, Greece, Hungary, Slovakia, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT03116347. Inclusion in this directory is not an endorsement.