A Phase 4 interventional study of Immunoglobulin replacement therapy (IGRT) in Secondary Antibody Deficiency, sponsored by Ottawa Hospital Research Institute. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-10.
Sponsored by Ottawa Hospital Research Institute · Phase 4, Interventional, and Diagnostic
Current treatment for patients with secondary antibody deficiency (SAD) is Immunoglobulin replacement therapy (IGRT). There are currently no clinical guidelines for IGRT discontinuation in patients with SAD. This study will examine the IGRT discontinuation success rate and IGRT discontinuation rate in patients.
Immunoglobulin replacement therapy (IGRT) is a mainstay treatment for SAD and has been shown to reduce the risk of infection and increase quality of life in patients with SAD. Current guidelines recommend that patients with severe hypogammaglobulinemia (IgG \<4 g/L) or patients with a history of recurrent or severe infections should be offered IGRT, which can be administered intravenously on a monthly basis or more frequently by subcutaneous infusions. There are currently no clinical guidelines for IGRT discontinuation. Although research conducted at the Ottawa Hospital indicates successful discontinuation of IGRT, clinicians need a tool to predict the recovery of humoral immunity and the risk of infection in these patients in order to determine whether IGRT may be safely discontinued.
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Exclusion Criteria:
Participants will be tested to determine Switched memory B cells (SMB) levels. If SMB cells are ≥ 2%, IGRT will be discontinued. If SMB cells are \< 2%, the patient will remain on IGRT and a maximum of 40 mL of blood will be drawn again in 3-6 months to reassess SMB levels and eligibility for IGRT discontinuation.
Drug: Immunoglobulin replacement therapy (IGRT)
IGRT discontinuation will be dependent on participant's SMB levels. If SMB cells are ≥ 2%, IGRT will be discontinued. If SMB cells are \< 2%, the patient will remain on IGRT and a maximum of 40 mL of blood will be drawn again in 3-6 months to reassess SMB levels and eligibility for IGRT discontinuation.
IGRT discontinuation sucess rate
IGRT discontinuation success rate defined as the proportion of patients with normal SMB levels who stop IGRT and experience less than or equal to 1 moderate infection and no severe infection within 12 months of IGRT discontinuation. Moderate infection will be defined as an infection that requires outpatient oral antimicrobial treatment. Severe infection will be defined as an infection that requires intravenous antimicrobial treatment and/or hospitalization.
Time frame: 12 months post discontinuation
IGRT discontinuation rate
IGRT discontinuation rate defined as the proportion of recruited adult patients with SAD who discontinue IGRT during the study period.
Time frame: 12 months post discontinuation
Change in Health-Related Quality of Life
Change in Health-Related Quality of Life (HRQoL) before and after IGRT discontinuation. The 36-item Short Form Survey (SF-36, RAND Corporation) will be used to obtain HRQoL data.
Time frame: Through study completion, an average of 1 year
Change in Health-Related Quality of Life
Change in Health-Related Quality of Life (HRQoL) before and after IGRT discontinuation. The Euroqol 5-dimension 5-level (EQ-5D-5L) questionnaire will be used to obtain HRQoL data.
Time frame: Through study completion, an average of 1 year
Cost saving potential
Calculated potential cost saving based on the study IGRT discontinuation rate using SMB as a marker for discontinuation.
Time frame: Through study completion, an average of 1 year
Receiver operating curve (ROC)
We will estimate a receiver operating curve (ROC) of SMB proportion as a predictor of successful discontinuation.
Time frame: Through study completion, an average of 1 year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute