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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NCT07573059

Evaluation of the Safety of Loargys Arginine Test System in Loargys-treated Patients

Recruiting
NAAges 0+Interventional
Immedica Pharma US Inc
~100 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:Loargys Arginine Test System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of AEs related to the Loargys Arginine Test System
Measured over Through study completion, up to 21 months
ARG1 Deficiency
1 sites across 1 states
Georgia1
  • Mattias Rudebeck, PhD · STUDY_DIRECTOR · Immedica Pharma US Inc
Head of Global Integrated Evidence Generation
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Eligibility criteria

Inclusion

Participant receiving treatment with commercialized Loargys for ARG1-D
Participant is willing to sign the Informed Consent Form

Exclusion

None
  • Incidence of AEs related to the Loargys Arginine Test SystemThrough study completion, up to 21 months