One-Shot gene therapy tested for Long-Term safety in rare metabolic disorder

NCT ID NCT03636438

First seen Nov 17, 2025 · Last updated Apr 12, 2026 · Updated 19 times

Summary

This study is tracking the long-term safety and effectiveness of a single-dose gene therapy for adults with a rare, inherited metabolic disorder called late-onset OTC deficiency. The therapy aims to deliver a working copy of a missing liver enzyme to help the body process ammonia. Only 11 adults who received the therapy in a previous study are being monitored for side effects and changes in their ammonia levels over time.

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Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Hopital Femme Mere Enfant

    Bron, Rhone, 69677, France

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Coruna, 15706, Spain

  • Hospital Universitario de Cruces. Servicio de Pediatria

    Barakaldo, Vizcaya, 48903, Spain

  • Icahn School of Medicine

    New York, New York, 10029, United States

  • M.A.G.I.C. Clinic

    Calgary, Alberta, T2E 7Z4, Canada

  • Queen Elizabeth Hospital, Department of Endocrinology

    Birmingham, B15 2TH, United Kingdom

  • The Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • University Hospital Cleveland Medical Center/Case Western Reserve University

    Cleveland, Ohio, 44106, United States

Conditions

Explore the condition pages connected to this study.