NCT04566692

A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency

A Multi-center, Single-Sequence, Open-label Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Subjects and Loading/Maintenance Dosing in Treatment-Naïve Subjects With Primary Immunodeficiency

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 6 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the concentration versus time curve (AUC) of total Immunoglobulin G (IgG) that is non-inferior to that produced by weekly administration of IGSC 20% in treatment-experienced participants with primary immunodeficiency (PI).

Conditions

• Primary Immunodeficiency

Interventions

Type	Name	Description
BIOLOGICAL	IGSC 20%	SC infusion pump.

Timeline

• Start date: 2020-11-24
• Primary completion: 2022-07-18
• Completion: 2022-07-25
• First posted: 2020-09-28
• Last updated: 2023-09-29
• Results posted: 2023-08-07

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study