NCT06805695 Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
| NCT ID | NCT06805695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | iECURE, Inc. |
| Condition | Ornithine Transcarbamylase Deficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 13 participants |
| Start Date | 2024-12-23 |
| Primary Completion | 2041-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 13 participants in total. It began in 2024-12-23 with a primary completion date of 2041-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
George Diaz, M.D., Ph.D
STUDY DIRECTOR
iECURE, Inc.
Frequently Asked Questions
Who can join the NCT06805695 clinical trial?
This trial is open to participants of all sexes, aged 7 Months or older, up to 15 Months, studying Ornithine Transcarbamylase Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06805695 currently recruiting?
Yes, NCT06805695 is actively recruiting participants. Contact the research team at medinfo@iecure.com for enrollment information.
Where is the NCT06805695 trial being conducted?
This trial is being conducted at Aurora, United States, New York, United States, London, United Kingdom.
Who is sponsoring the NCT06805695 clinical trial?
NCT06805695 is sponsored by iECURE, Inc.. The principal investigator is George Diaz, M.D., Ph.D at iECURE, Inc.. The trial plans to enroll 13 participants.