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

NCT06805695 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2025-02-03

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

No Intervention

No Intervention

Sponsors & Collaborators

  • iECURE, Inc.

    lead INDUSTRY

Principal Investigators

  • George Diaz, M.D., Ph.D · iECURE, Inc.

Eligibility

Min Age
7 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-23
Primary Completion
2041-07-31
Completion
2041-07-31
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06805695 on ClinicalTrials.gov