Safety Study of Loargys Arginine Test System in ARG1 Deficiency
This study is looking at the safety of a special test system called the Loargys Arginine Test System. This system is used for people who are already being treated with Loargys for Arginase 1 deficiency (ARG1-D). ARG1-D is a rare condition where your body can't properly break down a substance called arginine, which can cause serious health problems. Loargys is a treatment that helps lower arginine levels. Because Loargys keeps breaking down arginine even after a blood sample is taken, this test system uses a special substance to make sure blood test results are accurate. The main goal of this study is to see how many side effects (adverse events) are related to using the Loargys Arginine Test System. You can join if you are receiving commercial Loargys for ARG1-D and are willing to sign a consent form.
- Study design
- This study is designed to enroll 100 participants. It is an interventional study, meaning participants will receive a specific intervention.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for side effects related to the Loargys Arginine Test System through study completion, up to 21 months.
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Evaluation of the Safety of Loargys Arginine Test System in Loargys-treated Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mattias Rudebeck, PhD · STUDY_DIRECTOR · Immedica Pharma US Inc
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Incidence of AEs related to the Loargys Arginine Test SystemThrough study completion, up to 21 months