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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

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 6 of 14 entries
    • Site details revised at 12 of 12 sites
  2. Phase changed: Phase 1/2 → Phase 3v21
  3. Enrollment target: 8 to 20v20 Show 6 more changesShow less
    • Primary and study completion dates: Sep 2026 to Dec 2027
    • Primary endpoints: 4 to 8
    • Study sites: 10 to 12
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: 7 to 14
    • Study description shortened, about 40 words
  4. Study sites: 9 to 10v19
  5. Site contacts updated at 1 of 9 sitesv18
Show 16 earlier versionsHide 16 earlier versions
  1. Site contacts updated at 1 of 9 sitesv17
  2. Enrollment target: 13 to 8v16 Show 4 more changesShow less
    • Primary endpoints: 2 to 4
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 6 to 7
    • Study title shortened, about 1 word
  3. Study sites: 8 to 9v15
  4. Study sites: 7 to 8v14
  5. Site details revised at 1 of 7 sitesv13
  6. Study sites: 6 to 7v12
  7. Study sites: 5 to 6v11
  8. Study sites: 4 to 5v10
  9. Study sites: 3 to 4v9
  10. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 2 to 3
    v8
  11. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v7
  12. Site details revised at 1 of 2 sitesv6
  13. Study sites: 1 to 2v5
  14. Start date changed from estimate of Apr 2024 to Apr 8, 2024
    • Eligibility criteria shortened, about 206 words
    • Secondary endpoints: 8 to 6
    • Study description shortened, about 14 words
    v4
  15. Site contact updatedv3
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 detoxifying of ammonia. Individuals with OTC deficiency can develop elevated levels of ammonia in the blood, potentially resulting in severe consequences, including cumulative and irreversible neurological damage, coma, and death. The most severe form presents shortly after birth and occurs more commonly in boys than girls. This is a Phase 1/2/3, open-label, multicenter study evaluating the safety, efficacy, and dose of ECUR-506 in male babies with neonatal-onset OTC deficiency. The primary objective is to evaluate the safety, tolerability, and efficacy of up to three dose levels of ECUR-506 following intravenous (IV) administration of a single dose.
Trial Details
NCT Number NCT06255782
Lead Sponsor iECURE, Inc.
Conditions
(from sponsor)		 Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease, Ornithine Carbamoyltransferase Deficiency (Disorder), Urea Cycle Disorders, Inborn
Related terms Amino Acid Metabolism, Inborn Errors, Brain Diseases, Brain Diseases, Metabolic, Brain Diseases, Metabolic, Inborn, Central Nervous System Diseases, Genetic Diseases, Inborn, Genetic Diseases, X-Linked, Hyperammonemia, Liver Diseases, Metabolic Diseases, Metabolism, Inborn Errors, Nervous System Diseases, Ornithine Carbamoyltransferase Deficiency Disease, Urea Cycle Disorders, Inborn
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov