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

PHASE3CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

January 31, 2016

Study Completion Date

May 31, 2016

Conditions
Primary Immune Deficiency DisordersCommon Variable ImmunodeficiencyX-linked AgammaglobulinaemiaHyper-IgM Syndrome
Interventions
BIOLOGICAL

Gammaplex (5%)

BIOLOGICAL

Gammaplex 10

Trial Locations (17)

20815

Institute for Asthma and Allergy, Chevy Chase

22030

O&O Alpan, LLC, Fairfax

33021

Joe DiMaggio Children's Hospital, Hollywood

33408

Allergy Associates of the Palm Beaches, PA, North Palm Beach

43617

Asthma and Allergy Center, Toledo

60612

Rush University Medical Center, Chicago

75230

Dallas Allergy Immunology Research, Dallas

80112

IMMUNOe International Research Centers, Centennial

84113

University of Utah Primary Children's Hospital, Salt Lake City

85224

Arizona Allergy Associates, Chandler

90027

Childrens Hospital Los Angeles, Los Angeles

90095

UCLA Medical Center, Los Angeles

90806

Miller Children's Hospital, Long Beach

98225

Bellingham Asthma Allergy and Immunology Clinic, Bellingham

Unknown

Egyesitett Szent Istvan es Szent Laszlo Korhaz, Budapest

CF14 4XW

University Hospital of Wales, Cardiff

NW3 2QG

The Royal Free Hospital and Medical School, London

Sponsors
All Listed Sponsors
lead

Bio Products Laboratory

OTHER