drugset
drugset / Trial / NCT04561115

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency

NCT04561115 ↗

Phase 3 Completed 33 enrolled Grifols Therapeutics LLC
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to demonstrate bioequivalence of IVIG-PEG with Gamunex-C (IVIG-C) at steady-state as determined by comparing total Immunoglobulin G (IgG) area under the concentration-time curve during the defined dosing interval (\[AUC0-τ\] either every 3 weeks \[AUC0-21 days\] or every 4 weeks \[AUC0-28 days\]) and maximum concentration in a dosing interval (Cmax) in participants diagnosed with primary humoral immunodeficiency (PI) currently receiving chronic IVIG replacement treatment.

Timeline

Start
2020-09-02
Primary completion
2022-03-28
Completion
2022-03-28

Drugs

EvaluationDrugModalityDoseRoute
Subject IVIG-PEG Protein / enzyme biologic 200 mg/kg Intravenous
Subject IVIG-PEG Protein / enzyme biologic 800 mg/kg Intravenous
Comparator Immune Globulin Intravenous (Human) Protein / enzyme biologic 200 mg/kg Intravenous
Comparator Immune Globulin Intravenous (Human) Protein / enzyme biologic 800 mg/kg Intravenous

Indications

immunodeficiency disease