Study to compare Gammaplex 10% & 5% in Primary Immunodeficiency
Research type
Research Study
Full title
A Phase III, Multicentre, Open-label, Randomised, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases
IRAS ID
138523
Contact name
Ronnie Chee
Contact email
Sponsor organisation
Bio Products Laboratory
Eudract number
2013-002290-21
ISRCTN Number
NCT01963143
Clinicaltrials.gov Identifier
Research summary
This is a medical research study investigating the study drug, Gammaplex 10, an experimental drug that is being tested for Primary Immunodeficiency Disease (PID).
Experimental means that the study drug is not yet approved.
Primary immunodeficiencies are disorders in which part of the body’s immune system is missing or does not function normally.
Patients with PID do not have enough immunoglobulins (IgG) in their blood. IgG are proteins that provide protection against disease and infections.
Patients require treatment called replacement therapy where they receive IgG that has been purified from donated human blood.
Gammaplex 10 is an intravenous IgG product (IGIV). Intravenous means that the drug is given using a needle that is placed directly into the vein.
This study will involve about 30 adults (aged between 16 and 55 years) and approximately 12-18 children (aged between 2 and 15 years)
Adults will receive 10 study drug infusions, meaning that they receive Gammaplex 10 and Gammaplex 5% (five infusions each)
Children will receive 5 study drug infusions (Gammaplex 10 only)
The purpose of this research study is to:
1. Test the levels of IgG in the blood (this is called pharmacokinetics or PK and tells us what the body does to the drug) after giving Gammaplex 10
2. Look at the safety of Gammaplex 10
The results collected from the adult participants will be compared with data obtained from Gammaplex 5% (an approved IGIV product)Depending on the study drug dosing schedule, adults could be in the study 38 or 48 weeks while children could be in the study 23 or 28 weeks.
A participant information sheet describing the study will be provided.
Participation in this study is entirely voluntary. Signed and dated informed consent/ assent /parent consent will be obtained from each participant before any study procedures are performed.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/0278
Date of REC Opinion
30 Apr 2014
REC opinion
Further Information Favourable Opinion