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ACTIVE NOT RECRUITING
NCT04354129

Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency.

Sponsor: University of Alberta

View on ClinicalTrials.gov

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 Cutaquig® by rapid manual push method will improve the safety, tolerability and patient satisfaction of participants with PID or SID. Cutaquig® by rapid push is already approved in Canada and has proven to be efficacious in preventing significant infection. However, relative safety, tolerability, and patient satisfaction have not been studied in these patients. The information gained from this study will improve the safety and tolerability knowledge database and will support the optimal use of Cutaquig® - thus benefitting both physicians and patients.

Official title: Safety, Tolerability, and Patient Satisfaction of 16.5% Subcutaneous Immunoglobulin (Cutaquig®) Treatment by Rapid Push in Patients With Primary or Secondary Immunodeficiency (PID or SID)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

36

Start Date

2023-04-01

Completion Date

2025-09

Last Updated

2025-01-28

Healthy Volunteers

No

Interventions

DRUG

Cutaquig®

Immunoglobulin replacement therapy with subcutaneous injections of Cutaquig® 165 mg/mL at home.

Locations (1)

University of Alberta

Edmonton, Alberta, Canada