Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Second… (NCT04354129) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency.
Canada36 participantsStarted 2023-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
Patients currently participating in another interventional study at the time of inclusion
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is observational and is looking specifically at the safety and tolerability of Cutaquig's infusion rate, does that mean my treatment experience and any side effects I have would just be recorded rather than anything being changed about my care?
2This trial is listed as 'active, not recruiting,' which means they're no longer enrolling new patients — does that affect whether I could still access Cutaquig as a treatment option outside of this study?
3Because this is a Phase NA observational study rather than a controlled clinical trial, what does that mean for how much is already known about Cutaquig's safety compared to other subcutaneous immunoglobulin therapies I might consider?
4Given that the study focuses on infusion rate tolerability, are there specific reactions or side effects at the injection site I should be aware of and watching for if Cutaquig is something my doctor is considering for me?
5Whether or not I could join this study, would subcutaneous immunoglobulin like Cutaquig be a reasonable option for my specific type of immunodeficiency, and how does it compare to intravenous immunoglobulin or other standard treatments?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.