drugset / Trial / NCT02269163
Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
Non-randomizedSequentialOpen-labelTreatment
Summary
Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product \[IMP\]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).
Timeline
- Start
- 2016-01-26
- Primary completion
- 2019-01-11
- Completion
- 2019-01-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prometic Immune Globulin Intravenous | Unknown | — | Intravenous |
| Comparator | Gammargard | Unknown | — | Intravenous |
| Comparator | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | — | Intravenous |
| Comparator | Octogam | Unknown | — | Intravenous |