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

Phase 3

Completed

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

• Registration Number: NCT01963143
• Lead Sponsor: Bio Products Laboratory

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Study Start: 2014-02
• Primary Completion: 2016-01
• Study Completion: 2016-05
• Status Verified: 2017-02
• Results First Submitted: 2017-02-10
• Results First Submitted QC: 2017-02-10
• Last Update Submitted: 2017-02-10
• Results First Posted: 2017-03-29
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects	After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14, 21 and 28 days post-infusion

Secondary Outcome Measures

Name	Time	Method
Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects	After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14 and 21 days post-infusion
Secondary Bioequivalence Analysis - IgG Trough Levels	After a minimum 5 infusions on each product, at pre-infusion.

Trial Locations

Locations (17)

Arizona Allergy Associates; 🇺🇸 Chandler, Arizona, United States

Miller Children's Hospital; 🇺🇸 Long Beach,, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles,, California, United States

Childrens Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

IMMUNOe International Research Centers; 🇺🇸 Centennial, Colorado, United States

Joe DiMaggio Children's Hospital; 🇺🇸 Hollywood, Florida, United States

Allergy Associates of the Palm Beaches, PA; 🇺🇸 N Palm Beach, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Institute for Asthma and Allergy; 🇺🇸 Chevy Chase, Maryland, United States

Asthma and Allergy Center; 🇺🇸 Toledo, Ohio, United States

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