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An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency

Sponsored by iECURE, Inc.

Quick Self-Assessment

See if you qualify and express your interest

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Nov 14, 2025

Phase

Clinical Trial

Sponsor

iECURE, Inc.

Enrollment Target

8

Start Date

Apr 2024

๐Ÿ“Š
1 of 8 participants interested
13% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

Ornithine Transcarbamylase (OTC) deficiency, the most common urea cycle disorder, is an inherited metabolic disorder caused by a genetic defect in a liver enzyme responsible for detoxification of ammonia. Individuals with OTC deficiency can build-up excess levels of ammonia in their blood, potentially resulting in devastating consequences, including cumulative and irreversible neurological damage, coma and death.

Who Can Participate

Inclusion Criteria

Male sex 2. Gestational or adjusted (corrected) gestational age โ‰ฅ 37 weeks 3. Age at screening is 24 hours to 7 months 4. Weight โ‰ฅ 3.5 kg and โ‰ค 13.5 kg at screening 5. Has received age-appropriate vaccinations 6. Genetically confirmed OTCD 7. Severe neonatal OTCD defined by hyperammonemic crisis with elevated ammonia level of \>560 ฮผmol/L and clinical symptoms within first week of life 8. Current or historical biochemical profile consistent with OTCD 9. Participant's parent(s)/LAR must be able to comprehend and be willing to provide a signed IRB/IEC-approved ICF. Key

Exclusion Criteria

Neonatal diagnosis of severe to profound Hypoxic Ischemic Encephalopathy due to birth injury 2. Requiring urgent liver transplant due to liver failure as assessed by the PI. 3. Contiguous gene deletion involving the OTC gene and including at least the CYBB gene on the telomeric side or the TSPAN7 gene on the centromeric side. 4. Known or suspected major organ injury/dysf

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

8 participants

๐ŸŽ‚

Age Range

24 Hours - 7 Months

โšง

Gender

MALE

๐Ÿข

Sponsor

iECURE, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

New York

New York

Location available
View New York location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

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Looking for OTC Deficiency Treatment in Los Angeles?

Join others in California exploring innovative treatment options through clinical research

OTC Deficiency Treatment Options in Los Angeles, California

If you're searching for OTC Deficiency treatment in Los Angeles, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Los Angeles, Aurora, New York and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with OTC Deficiency. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 8 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for OTC Deficiency?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for OTC Deficiency

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This OTC Deficiency Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06255782. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.