IgLINK Non-interventional study of IgRT in secondary immune deficiency
Research type
Research Study
Full title
Effectiveness of immunoglobulin replacement therapy in patients with secondary immune deficiency: a multicentre chart review study
IRAS ID
293315
Contact name
Nicholas Martinez-Calle
Contact email
Sponsor organisation
CSL Behring
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 5 months, 17 days
Research summary
Immunodeficiency diseases are conditions where compromise of the patients’ immune system weakens the ability to fight infection. Primary immune deficiency (PID) is due to inborn conditions; secondary immune deficiency (SID) is due to external causes, including underlying conditions or consequent to certain treatments. \nPertinent to this study, the underlying conditions associated with SID are haematological (blood) cancers e.g. chronic lymphocytic leukaemia, multiple myeloma, non-Hodgkin’s lymphoma, and the treatments associated with SID which may weaken the immune system are solid organ transplant, or B- or T-cell depleting therapies including CAR-T.\nImmunoglobulin replacement therapy (IgRT) has been shown to reduce infection in patients with PID and SID by helping to raise immunoglobulin levels in the blood to normal levels. The aim of this research study is to help to understand how well IgRT works for patients in the real world in terms of preventing infections and improving outcomes in the longer term. \nThis is a multi-centre, retrospective, observational study with matched cohorts. Patients in the non-IgRT cohort will be matched 1:1 to patients receiving IgRT (specifically Privigen or Hizentra). Data will be collected from the hospital medical records of 425 IgRT and 425 non-IgRT patients. Eligible patients in England between 1st January 2014 and 31st December 2019 will be included in the study.\nThe study will take place at up to 10 centres across England, including at least 425 patients who received Hizentra or Privigen brands of IgRT, and at least 425 matched patients who did not receive any IgRT.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
21/SW/0148
Date of REC Opinion
28 Oct 2021
REC opinion
Further Information Favourable Opinion