Safety of the Loargys Arginine Test System for people receiving Loargys
A Multicenter, Prospective Study Assessing the Safety of Loargys Arginine Test System for Determining Arginine in Loargys-treated Patients
This tests a special blood-collection tube and lab test that stop Loargys from changing samples so arginine levels can be measured accurately in people with ARG1 deficiency who take Loargys.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 0 Years to 100 Years |
| Sex | All |
| Sponsor | Immedica Pharma AB Industry-sponsored |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT07573059 on ClinicalTrials.gov |
What this trial studies
The study tests the Loargys Arginine Test System, which combines blood collection tubes containing nor-NOHA with a laboratory arginine assay, in patients treated with commercial Loargys for ARG1 deficiency. Because Loargys continues to break down arginine after a blood draw, nor-NOHA is used in the tubes to halt that activity and preserve true arginine levels. Participants on individualized Loargys dosing will have blood samples collected using the system and analyzed by a standard lab method to observe safety and performance. The study is single-site and focuses on the safety and accuracy of the collection and testing process rather than altering Loargys treatment.
Who should consider this trial
Good fit: Ideal candidates are people with ARG1 deficiency who are currently receiving commercial Loargys and are willing to sign the informed consent form.
Not a fit: People not treated with Loargys, those unwilling to provide blood samples, or those unable to attend the study site are unlikely to benefit from this test system.
Why it matters
Potential benefit: If successful, this could provide more accurate arginine measurements to help clinicians dose Loargys more safely and avoid misleading lab results.
How similar studies have performed: Using inhibitors in collection tubes to stop enzyme or drug activity in blood samples is an established laboratory practice, but this specific Loargys arginine test system is a new, application-specific approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant receiving treatment with commercialized Loargys for ARG1-D * Participant is willing to sign the Informed Consent Form Exclusion Criteria: * None
Where this trial is running
Atlanta, Georgia
- Rare Disease Research — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Study coordinator: Head of Global Integrated Evidence Generation
- Email: clinical@immedica.com
- Phone: +46(0)853339500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.