Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595
Research type
Research Study
Full title
An open-label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID)
IRAS ID
207646
Contact name
Ronnie Chee
Contact email
Sponsor organisation
Biotest AG
Eudract number
2015-003652-52
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 6 days
Research summary
This study is being carried out internationally across 23 centres on patients who have Primary immunodeficiency diseases (PIDs) in both paediatric and adult populations. In this condition the body does not produce sufficient amounts of proteins called immunoglobulins (Ig) or antibodies which are found in the blood plasma and are important for fighting infections. People who do not produce sufficient antibodies are more at risk of developing certain types of infections than people with normal amounts of antibodies.
The main purpose of this study is to find out how the body processes Immunoglobulin G, and how safe a substance called BT595 is and how well it works when given to patients with PID.
BT595 is not yet registered for use in patients with PID and this is the first time it will be tested in humans but it is very similar to drugs already established and on the market for treating PID such as Intratect®. It is hoped that the rate of serious bacterial infections will be significantly reduced through treatment with BT595.
Participants in the study will have blood samples taken at varying time-points to find out how long the immunoglobulin study compound stays in the body.Recruitment is targeted at 60 participants enrolled to ensure data is available for at least 50 evaluable participants. At least 20 participants should be adults (18-75 years, inclusive). Note: In the United Kingdom No patients < 18 are allowed to participate in the trial.
Participants will receive 52 weeks of treatment with BT595, visiting the clinic 18 times if they receive their current treatment every 3 weeks and 14 times for treatment received every 4 weeks.
At the end of the study, participants will return to their standard care treatment and will no longer be entitled to treatment with BT595.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/2129
Date of REC Opinion
2 Feb 2017
REC opinion
Further Information Favourable Opinion