Trial intelligence / Profile preview

IGSC 20% Biweekly Dosing in PI

NCT04566692Phase 4Completed

Sponsor
Grifols
Start
Nov 2020
Primary completion
Jul 2022
Modality
Biologic, rProtein (Recombinant Protein)
Countries
1
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Overview

Phase 4, open-label trial of immune globulin subcutaneous, human-klhw in primary immunodeficiency (PI) (2 arms), sponsored by Grifols. Primary endpoints: Steady-State Area Under the Curve (AUC) of Total IgG Over a Regular Dosing Interval (tau) - Weekly Administration at Week 15 and Steady-State Area Under the Curve (AUC) of Total IgG Over a Biweekly Dosing Interval - Biweekly Administration at Week 32. Started Nov 2020; status: completed.

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Drugs

immune globulin subcutaneous, human-klhw
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Conditions

primary immunodeficiency (PI)

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