Status:
COMPLETED
Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
CSL Behring
Conditions:
Hypogammaglobulinemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Tolerability of home subcutaneous immunoglobulin (ScIG) for replacement therapy for hypogammaglobulinemia in allogeneic HCT patients. A financial analysis comparing the cost of ScIG with intravenous i...
Detailed Description
The purpose of the study is to determine whether home subcutaneous immunoglobulin (ScIG) is tolerated as replacement therapy for hypogammaglobulinemia in patients that have undergone allogeneic hemato...
Eligibility Criteria
Inclusion
- Age over 18 years
- Patients at least 100 days post allogeneic hematopoietic cell transplantation for any benign or malignant hematological disease, from a related or unrelated donor
- Patients who are already established on regular IVIG
- Patients eligible for immunoglobulin replacement with an IgG \<7mg/L, or normal IgG total but IgG2 or IgG4 below normal
- Patients with IgG =\>7g/L but with at least 2 prior episodes of bacterial infection (proven or suspected eg. sinusitis diagnosed on CT)
- No other medical condition which would preclude treatment with immunoglobulin
- Willing to participate and sign informed consent
Exclusion
- Previous serious adverse reaction from IVIG or products from Hizentra (polysorbate)
- Other serious medical or psychiatric disorders which may interfere with the patient's ability to participate in the study, or interfere with study assessment (e.g. advanced congestive heart failure, severe liver disease, renal failure, disease relapse or secondary malignancy, schizophrenia, paranoid psychosis)
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03401268
Start Date
February 1 2018
End Date
May 1 2019
Last Update
May 9 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9