Gene therapy for rare metabolic disorder shows promise in Long-Term safety check

NCT ID NCT03636438

First seen Nov 17, 2025 · Last updated May 10, 2026 · Updated 23 times

Summary

This study checks the long-term safety of a one-time gene therapy (DTX301) in 11 adults with late-onset OTC deficiency, a rare genetic disorder that causes dangerous ammonia buildup. Participants had already completed one year of the main study and will be followed for several more years. The goal is to see if the treatment remains safe and helps control ammonia levels without needing lifelong medication.

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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.