Status:
ACTIVE_NOT_RECRUITING
Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency.
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Octapharma
Conditions:
Primary Immune Deficiency Disorder
Secondary Immune Deficiency
Eligibility:
All Genders
18+ years
Brief Summary
This study will assess the relative safety, tolerability, and participant satisfaction in participants using the rapid manual push method with Cutaquig®. The hypothesis being that treatment with Cutaq...
Detailed Description
Primary and secondary immunodeficiency diseases (PID and SID, respectively) affect the development and/or function of the immune system, resulting in increased frequency of infection. Treatment of the...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 years)
- Who have PID or SID requiring IgG replacement therapy
- For whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of Cutaquig® 165 mg/mL at home
- Having signed an informed consent form
Exclusion
- Patients currently participating in another interventional study at the time of inclusion
Key Trial Info
Start Date :
April 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04354129
Start Date
April 1 2023
End Date
September 1 2025
Last Update
January 28 2025
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3