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The CLEAR Study

The CLEAR Study helps confirm the safety of an investigational specialized blood testing system used to accurately measure arginine in people with Arginase 1 Deficiency (ARG1-D).

The CLEAR Study

The CLEAR Study helps confirm the safety of an investigational specialized blood testing system used to accurately measure arginine in people with Arginase 1 Deficiency (ARG1-D).

This website provides information about the CLEAR Study, a clinical research study designed to help confirm the safety of an investigational specialized blood collection and testing system for people living with Arginase 1 Deficiency (ARG1-D) who are being treated with LOARGYS® (pegzilarginase-nbln). For families managing this rare condition, precise measurement of arginine is not a technical detail; it is a critical part of care. Understanding the purpose of this study can help families make informed decisions and know what to expect during participation.

WHAT IS THE CLEAR STUDY?

The CLEAR Study is a clinical research study designed to evaluate the safety of an investigational special blood testing system used during treatment with LOARGYS for people with ARG1-D. This study focuses on the safety of the investigational blood collection and testing process to measure arginine, not the actual medication (LOARGYS). LOARGYS has already been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ARG1-D. All the available information about the CLEAR Study will be provided during the informed consent process by the CLEAR Study team. Participants will be able to ask questions during that process.

WHY IS THIS STUDY IMPORTANT?

People with ARG1-D have high levels of arginine in their blood. LOARGYS lowers arginine levels and continues to lower arginine levels in the blood sample tube after blood is drawn. A specialized blood collection and testing system is necessary to ensure accurate results. This study helps confirm that the investigational system is safe and is a requirement of the FDA when treating with LOARGYS.

WHO CAN TAKE PART?

People may take part if:
  • They have ARG1-D
  • Their doctor has prescribed LOARGYS
  • They are willing to sign the informed consent

WHO CAN TAKE PART?

People may take part if:

  • They have ARG1-D
  • Their doctor has prescribed LOARGYS
  • They are willing to sign the informed consent

WHAT WILL HAPPEN DURING THE STUDY?

The CLEAR Study staff will perform a routine blood draw prior to select treatment visits. The treating doctor and the CLEAR Study staff will notify the participant when these blood draws should take place. Trained CLEAR Study staff will perform the routine blood draw at home or at a convenient location close to the LOARGYS dose administration.

The CLEAR Study team will watch for any side effects related to blood collection or testing. Samples will be analyzed to measure arginine levels and results sent to the treating doctor. Individual participation will continue for up to 21 months. The CLEAR Study will continue until FDA clearance of the investigational blood test system.

WHAT IS INFORMED CONSENT?

Informed consent is a process that provides participants with the information needed to understand what is involved in this study. During this process, the CLEAR Study team will explain the study, including its benefits and risks. Participants will receive an informed consent form to read and consider and are encouraged to ask the CLEAR Study team to explain any part that is not clear.

Participation is voluntary. Individuals are free to decide whether to take part in the study. If they choose to participate, they will sign the consent form and receive a copy for their records.

IS PARTICIPATION REQUIRED?

No. Participation in the study is voluntary. However, all patients receiving LOARGYS are required to participate in the CLEAR Study
to receive treatment with LOARGYS.

PROTECTION OF PERSONAL INFORMATION

Participant privacy is very important.

–     Participants will be assigned a unique study number. Names will not appear on study samples or reports.
–     Blood samples sent to the laboratory are labeled only with the unique study number.
–     Study information is stored securely and accessed only by authorized personnel.
–     Study results may be published, but only in summary form. Individual participants will not be identified.
–     This study follows privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA).

If you have questions about this study or how participant information is protected, please speak with CLEAR Study staff.

Patient FAQs

Important Notice: This FAQ is provided for informational purposes only. It does not provide medical advice, diagnosis, or treatment recommendations. Always talk with your doctor or health care provider about medical decisions, treatment options, and questions related to your care.

The CLEAR Study is a clinical research study of an investigational special blood test system. This investigational system measures arginine levels in people with Arginase 1 Deficiency (ARG1-D) who are treated with LOARGYS® (pegzilarginase-nbln).

No. LOARGYS is already approved by the U.S. Food and Drug Administration (FDA).

This study does not test the medicine. It focuses only on the investigational blood collection tubes and lab test used to measure arginine levels during LOARGYS treatment.

People who have ARG1-D and are receiving LOARGYS treatment may take part.

LOARGYS continues to lower arginine levels even after blood is drawn. Without a special blood collection tube, test results could show arginine levels that are lower than they truly are. The CLEAR Study helps ensure the safety of the investigational blood testing system.

Blood samples are collected before certain treatment visits using an investigational special collection tube. These blood draws are part of routine care. The CLEAR Study team watches for any side effects related to blood collection or testing.

Each person may be followed for up to 21 months. The study continues until FDA clearance of the investigational blood test system.

No additional clinic visits will be required. However, visits with the CLEAR Study team will take place when an arginine blood draw is needed. The CLEAR Study will provide a trained home health nurse who can perform the blood draw at home or other convenient location. The sample will not be collected by the treating doctor. However, the results of the test will be provided to them.

Informed consent is a process that provides participants with the information needed to understand what is involved in this study. During this process, the CLEAR Study team will explain the study, including its benefits and risks. Participants will receive an informed consent form to read and consider and are encouraged to ask the CLEAR Study team to explain any part that is not clear.

Participation is voluntary. Individuals are free to decide whether to take part in the study. If they choose to participate, they will sign the consent form and receive a copy for their records.

Yes, participation is voluntary. However, taking part in the CLEAR Study is necessary to receive treatment with LOARGYS until FDA clearance of the investigational blood test system.

Yes. A participant may leave the study at any time. The treating doctor will explain how this affects treatment. If someone leaves the study, LOARGYS treatment will also stop.

Each participant receives a unique study number. Names are not used on samples or reports. Information is stored securely and shared only with authorized staff. Results are reported in summary form only.

The study is sponsored by Immedica Pharma US Inc. and conducted by a central CLEAR Study team. The CLEAR Study has been reviewed and approved by ethics committees and the FDA.

Questions should be directed to the treating doctor or the CLEAR Study staff.

HCP FAQs

This FAQ is intended for healthcare professionals (HCPs) involved in the treatment of patients with Arginase 1 Deficiency receiving LOARGYS® (pegzilarginase-nbln). It provides an overview of the CLEAR Study, the rationale for the investigational test system, and how participation may impact clinical workflow.

The CLEAR Study is a prospective, non-pivotal Investigational Device Exemption (IDE) study designed to evaluate the safety of the investigational LOARGYS Arginine Test System when used to measure plasma arginine levels in patients with Arginase 1 Deficiency (ARG1-D) treated with LOARGYS. The study evaluates the safety of the investigational blood sampling system only and does not assess drug efficacy or safety.

The investigational LOARGYS Arginine Test System consists of two components:

  1. The Nor-NOHA Blood Collection Tube utilized in the blood sampling of the participant, and handling of the sample up until the sample is
    placed in a cryovial.
  2. The LC-MS/MS Arginine Assay, starting with the transfer of plasma into cryovials which are shipped to the laboratory facility and continuing
    until sample analysis is completed and arginine concentration in the sample is determined.

LOARGYS is an active enzyme therapy that continues to degrade arginine ex vivo after blood collection. Without inhibition, post-sampling degradation can result in artifactually low arginine values. One component of the investigational LOARGYS Arginine Test System is a collection tube pre-filled with Nω-hydroxy-nor-Arginine (nor-NOHA), an enzyme inhibitor used to inhibit post-sampling degradation of arginine by LOARGYS. This inhibitor is required to reduce the risk of erroneously low measurement of arginine levels. The CLEAR Study is part of a post-marketing commitment established by the U.S. Food and Drug Administration (FDA) and will continue until clearance of the investigational test system for routine U.S. clinical use.

No. LOARGYS is already approved by the FDA. Please review the full Prescribing Information for more details. This study does not evaluate the efficacy, safety, or dosing of LOARGYS. It focuses solely on the device-related safety of the investigational LOARGYS Arginine Test System.

The CLEAR Study is evaluating the safety of the investigational LOARGYS Arginine Test System, which includes the Nor-NOHA Blood Collection Tube and a quantitative LC-MS/MS arginine assay performed at a CLIA-approved laboratory.

All U.S. patients with ARG1-D receiving LOARGYS, including newly initiating and established patients.

Yes. Participation in the CLEAR Study is required by the FDA for U.S. patients receiving LOARGYS until FDA clearance of the investigational test system is obtained.

Other than obtaining the baseline plasma arginine concentration as per standard clinical practice, all arginine blood draws after the initiation of LOARGYS fall under the CLEAR Study. The blood draws must be obtained by the CLEAR Study team prior to LOARGYS administration at designated timepoints. Testing should be obtained prior to the fifth infusion of LOARGYS in naive patients and as described in the full Prescribing Information during dosage adjustments. Testing may also be obtained as clinically indicated.

Blood samples are collected by CLEAR Study home health nurses at the patient’s home or another predetermined, convenient location. Samples are not collected by treating HCPs or clinic staff.

Yes. Arginine results are returned to the treating HCP, with an anticipated turnaround time within seven days.

Treating HCPs manage LOARGYS administration, review arginine results, make dosing decisions according to the Full Prescribing Information and standard clinical practice and coordinate with the CLEAR Study team when blood draws are needed. They are not responsible for investigational test system accountability or sample logistics.

Participants may be followed for up to 21 months. The study continues until FDA clearance of the investigational test system.

The primary endpoint is the incidence of adverse events related to the investigational LOARGYS Arginine Test System.

The CLEAR Study team manages all aspects related to study conduct. This includes obtaining informed consent, performing blood draws, monitoring for adverse events, processing collected samples, and reporting study results.

The study is sponsored by Immedica Pharma US Inc., conducted by a central research site, and overseen by the FDA and institutional review board (IRB) review.

Treating HCPs may contact the CLEAR Study team or Immedica Medical Affairs with questions.

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