Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
iECURE, Inc.
Study ID
NCT06805695
Status
Recruiting
Apply to this trial

Conditions

  • Ornithine Transcarbamylase Deficiency
  • Ornithine Transcarbamylase Deficiency Disease
  • Urea Cycle Disorders, Inborn

Eligibility Criteria

Sex
ALL
Age
7 Months - 15 Months
Healthy Volunteers
Not accepted

Interventions

  • No Intervention — OTHER
    No Intervention

Study Details

This LTFU is being conducted to assess long-term safety and durability of response in participants dosed with IP in a parent protocol, and to collect longitudinal natural history in enrolled but not dosed participants who also participated in a parent protocol.

Key Dates

First listed
Feb 3, 2025
Start date
Dec 23, 2024
Status verified
Aug 2026
Primary completion
Jul 31, 2041
Completion
Jul 31, 2041

Study Design

Enrollment
13 participants (estimated)

Arms

  • Arm: Enrolled and Dosed
    Previously dosed in a previous iECURE study.
  • Arm: Enrolled but Not Dosed
    Enrolled in a previous iECURE study, but not dosed.

Primary Outcome Measure

AE and SAE (incidence, severity, seriousness, and relatedness) [ Time Frame: Over 14.5 years post dosing with ECUR-506 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital of Colorado, Anshutz Medical CampusAuroraColorado80045
Lanie Dougherty
[email protected]
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Silvia Gunderson
[email protected]

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By research site
Children's Hospital of Colorado, Anshutz Medical Campus· Aurora, COIcahn School of Medicine at Mount Sinai· New York, NY

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