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

Conditions

• ARG1 Deficiency

Eligibility Criteria

Sex

ALL

Age

0 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Loargys Arginine Test System — DEVICE
  Loargys Arginine Test System

Study Details

Arginase 1 deficiency (ARG1-D) is a rare condition in which the body cannot properly break down a substance called arginine. This leads to high levels of arginine and related substances in the blood, which can cause serious health problems and reduce quality of life. Loargys is a new treatment designed to lower arginine levels in people with ARG1-D. It works by providing a modified version of a natural enzyme that breaks down arginine in the blood. The dose of Loargys is adjusted for each patient based on their arginine levels. Because Loargys continues to break down arginine even after a blood sample has been taken, to ensure accurate results, a special substance (called nor-NOHA) is added to the blood collection tubes to stop this process after the sample is taken. The arginine levels are then measured using a standard laboratory test. The Loargys Arginine Test System used in this study includes both the special blood collection tubes and the laboratory test used to measure arginine. The purpose of this study is to evaluate the safety of this test system when used to measure arginine levels in patients receiving Loargys.

Key Dates

Start date

Apr 17, 2026

Status verified

May 2026

Primary completion

Jul 15, 2027

Completion

Jul 15, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Other: Loargys Arginine Test System

Primary Outcome Measure

Incidence of AEs related to the Loargys Arginine Test System [ Time Frame: Through study completion, up to 21 months ]

Central Contacts

• Head of Global Integrated Evidence Generation
  +46(0)853339500
  [email protected]

Locations (1)

Find similar trials in Atlanta, GA