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RECRUITINGNCT06805695

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

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 d...

Lead sponsor: iECURE, Inc.•1 locations•View source on ClinicalTrials.gov

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Contacts

George Diaz, M.D., Ph.D.

CONTACT

1-877-694-3558 medinfo@iecure.com

Sponsors

Lead Sponsor

iECURE, Inc.

This is a 14.5 year LTFU protocol to assess long term safety and clinical response to IP as well as to capture natural disease history of participants not dosed with IP in a parent protocol. No IP is provided as part of this protocol. Participants will remain on standard of care medication as indicated and prescribed by their physicians.

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Enrolled in an iECURE parent protocol and have either completed or discontinued that protocol
•2. Participant parent(s)/LAR is willing and able to adhere to the protocol requirements.
•3. Consent was obtained by the participants parent(s)/LAR (and participant assent, where applicable), prior to any study-related data being collected.

Exclusion Criteria

•1\. Participants who enroll into an interventional drug or gene therapy clinical trial utilizing an IP other than the IP provided in the parent protocol will be excluded from this protocol.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 3, 2025Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment13

Start dateDec 2024

Last updatedFeb 3, 2025

Condition

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

Locations shown

Great Ormond Street Hospital

London

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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