NCT01963143

Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases

A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Bio Products Laboratory · Academic / Other
• Sex: All
• Age: 2 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of adult subjects. The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.

Conditions

• Primary Immune Deficiency Disorders
• Common Variable Immunodeficiency
• X-linked Agammaglobulinaemia
• Hyper-IgM Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Gammaplex (5%)
BIOLOGICAL	Gammaplex 10

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-01-01
• Completion: 2016-05-01
• First posted: 2013-10-16
• Last updated: 2017-03-29
• Results posted: 2017-03-29

Locations

17 sites across 3 countries: United States, Hungary, United Kingdom