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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 these disorders using Cutaquig® (a subcutaneous immunoglobulin infusion (SCIG)) was licensed in Canada in 2018 and has proven to be effective in preventing significant infection. Other brands of SCIG can be given by the participant using a syringe (called rapid manual push method), which shows the same efficacy as administration by a programmable pump. The rapid manual push method has the potential to improve quality of life, reduce infusion time, and reduce the cost of administration. This study will evaluate the safety, tolerability, and patient satisfaction of Cutaquig® by the rapid manual push method in participants with PID or SID. It will also compare the efficacy of Cutaquig with prior SCIG treatment, if applicable, in participants with PID or SID.

Official Title
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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)

Conditions
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Primary Immune Deficiency Disorder, Secondary Immune Deficiency

Intervention / Treatment
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* Drug: Cutaquig®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PID/SID Cutaquig Treated Patients<br>Immunoglobulin replacement therapy with subcutaneous injections of Cutaquig® 165 mg/mL at home. | Drug: Cutaquig®<br>* Immunoglobulin replacement therapy with subcutaneous injections of Cutaquig® 165 mg/mL at home.<br>* Other names: Immunoglobulin (human) subcutaneous 16.5% Solution for injection (165 mg/mL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Infusion Rate | The primary objective is to assess safety of cutaquig® in patients with PID or SID by rapid push at infusion volumes ranging from 15 mL/infusion site to a maximum of 60 mL/infusion site into a maximum of 4 infusion sites and assess safety of a maximum infusion speed of 120 mL/h for all sites combined (2 mL/min) | 6 months | 
| Tolerability of Infusion Rate | The primary objective is to assess tolerability of cutaquig® in patients with PID or SID by rapid push at infusion volumes ranging from 15 mL/infusion site to a maximum of 60 mL/infusion site into a maximum of 4 infusion sites and assess tolerability of a maximum infusion speed of 120 mL/h for all sites combined (2 mL/min) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | Key secondary objectives are to assess by a questionnaire time to infuse cutaquig® total volume infused per infusion site total volume infused per infusion frequency of infusion number of injection sites ease of infusion (injectability) Other secondary objectives are to assess patient quality of life (QoL) and patient satisfaction by using the EQ-5D-5L (descriptive system compromises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety and depression). compare the injectability of cutaquig® with prior SCIG administration if applicable | 6 months |