Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Conditions
Brief summary
AUC in the IV Phase: Steady-state AUC of total IgG over a 3-week dosing interval (τ) (i.e., AUC(0−21days) in participants with CIDP, AUC in the SC Phase: Steady-state AUC of total IgG over a weekly SC dosing interval (τ) (i.e., AUC(0−7days)) in participants with CIDP
Detailed description
Steady-state mean trough (pre-dose) concentration of total IgG following IV administration of IGIV-C 10% Q3W or SC administration of IGSC 20% QW.
Interventions
Sponsors
Grifols Therapeutics LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC in the IV Phase: Steady-state AUC of total IgG over a 3-week dosing interval (τ) (i.e., AUC(0−21days) in participants with CIDP, AUC in the SC Phase: Steady-state AUC of total IgG over a weekly SC dosing interval (τ) (i.e., AUC(0−7days)) in participants with CIDP | — |
Secondary
| Measure | Time frame |
|---|---|
| Steady-state mean trough (pre-dose) concentration of total IgG following IV administration of IGIV-C 10% Q3W or SC administration of IGSC 20% QW. | — |
Outcome results
None listed