Trials / Completed
CompletedNCT03401268
Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients
A Pilot Study to Assess Tolerability of Subcutaneous Immunoglobulin Treatment (Hizentra) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University Health Network, Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 immunoglobulin (IVIG) will also be performed.
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 hematopoietic cell transplantation (alloHCT). Secondary objective is to perform a financial analysis comparing the cost of ScIG with intravenous immunoglobulin (IVIG). The study hypothesis is that home based SCIG treatment is applicable and tolerated well for replacement treatment in alloHCT patients. This will be examined in two sets of patients recruited: A) Patients already on IVIG replacement therapy and B) Newly diagnosed patients with hypogammaglobulinemia. Economic analysis will be performed by comparing the cost with an equal number of patients retrospectively determined to have undergone treatment with IVIG.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | subcutaneous immunoglobulin | 24 patients demonstrating hypogammaglobulinemia post allogeneic HCT will be started on ScIG for a total of 6 months. Tolerability of the intervention will be assessed with qualitative questionnaires, as well as a financial analysis regarding the intervention. |
Timeline
- Start date
- 2018-02-01
- Primary completion
- 2019-05-01
- Completion
- 2019-05-01
- First posted
- 2018-01-17
- Last updated
- 2019-05-09
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03401268. Inclusion in this directory is not an endorsement.