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
• Interventions: Biological: Gammaplex (5%); Biological: Gammaplex 10

• 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

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 2 - Adults	Gammaplex 10	Gammaplex 10 - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days, followed by Gammaplex 5% - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days
Pediatrics	Gammaplex 10	Gammaplex 10 - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days
Treatment Sequence 1 - Adults	Gammaplex 10	Gammaplex 5% - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days, followed by Gammaplex 10 - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days
Treatment Sequence 1 - Adults	Gammaplex (5%)	Gammaplex 5% - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days, followed by Gammaplex 10 - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days
Treatment Sequence 2 - Adults	Gammaplex (5%)	Gammaplex 10 - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days, followed by Gammaplex 5% - 5 intravenous infusions at a dose of 300 to 800 mg/kg/infusion, given every 21 to 28 days

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

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

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

O&O Alpan, LLC; 🇺🇸 Fairfax,, Virginia, United States

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

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

Bellingham Asthma Allergy and Immunology Clinic; 🇺🇸 Bellingham, Washington, United States

The Royal Free Hospital and Medical School; 🇬🇧 London, United Kingdom

University Hospital of Wales; 🇬🇧 Cardiff, Wales, United Kingdom

Egyesitett Szent Istvan es Szent Laszlo Korhaz; 🇭🇺 Budapest, Hungary

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

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

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

Dallas Allergy Immunology Research; 🇺🇸 Dallas, Texas, United States

University of Utah Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States