drugset / Trial / NCT01884311

Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases

NCT01884311 ↗

Phase 3 Completed 38 enrolled Bio Products Laboratory
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

EvaluationDrugModalityDoseRoute
Subject Subgam Protein / enzyme biologic — Subcutaneous