drugset / Trial / NCT03238079
Study of PlasmaCap IG in Adults and Children With PIDD
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to investigate the efficacy, safety, tolerability, and pharmacokinetic profile of the investigational medicinal product (IMP) and to determine, on the basis of historical control data, how it compares with other 10% intravenous immunoglobulin (IGIV) products currently licensed in North America for the treatment of subjects with primary immune deficiency diseases (PIDD).
Timeline
- Start
- 2017-09-05
- Primary completion
- 2020-08-25
- Completion
- 2020-08-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Human immunoglobulin | Protein / enzyme biologic | 300 mg/kg | Intravenous |
| Subject | Human immunoglobulin | Protein / enzyme biologic | 900 mg/kg | Intravenous |