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

Cutaquig®

Vicki Voong, BScN

Bruce Ritchie, MD

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.

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.

At the infusion visits, blood samples will be collected for laboratory evaluation.

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

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)

1. 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
2. assess safety of a maximum infusion speed of 120 mL/h for all sites combined (2 mL/min)

1. 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
2. assess tolerability of a maximum infusion speed of 120 mL/h for all sites combined (2 mL/min)

Key secondary objectives are to assess by a questionnaire

1. time to infuse cutaquig®
2. total volume infused per infusion site
3. total volume infused per infusion
4. frequency of infusion
5. number of injection sites
6. ease of infusion (injectability) Other secondary objectives are to
7. 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).
8. compare the injectability of cutaquig® with prior SCIG administration if applicable

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency.	NCT04354129	Primary Immune ... Secondary Immun...	Cutaquig®	18 Years -	University of Alberta
Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency.	NCT04354129	Primary Immune ... Secondary Immun...	Cutaquig®	18 Years -	University of Alberta

Spots Global Cancer Trial Database for cutaquig®

Every month we try and update this database with for cutaquig® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cutaquig®

Every month we try and update this database with for cutaquig® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cutaquig® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.