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)

Pro00095620

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.

2023-04-01

2024-06-01

2024-06-01

Recruiting

30

Inclusion Criteria: * 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 Criteria: -Patients currently participating in another interventional study at the time of inclusion

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'At the infusion visits, blood samples will be collected for laboratory evaluation.'}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-05-17