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

A Phase 3, Multicenter, Open-label, Single-sequence, Cross-over, Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of IVIG-PEG Compared to Gamunex-C in Subjects With Primary Humoral Immunodeficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Immunodeficiency

Interventions

Type	Name	Description
BIOLOGICAL	Gamunex-C	Intravenous infusion.
BIOLOGICAL	IVIG-PEG	Intravenous infusion.

Timeline

• Start date: 2020-09-02
• Primary completion: 2022-03-28
• Completion: 2022-03-28
• First posted: 2020-09-23
• Last updated: 2023-06-05
• Results posted: 2023-06-05

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study