drugset / Trial / NCT01884311
Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
NaSingle-groupOpen-labelOther
Summary
The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin (IGIV) therapy.
Timeline
- Start
- 2015-08-20
- Primary completion
- 2017-05-25
- Completion
- 2017-05-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Subgam | Protein / enzyme biologic | — | Subcutaneous |