Gene therapy aims to tame deadly ammonia spikes in rare disease

NCT ID NCT05345171

First seen Nov 01, 2025 · Last updated May 14, 2026 · Updated 21 times

Summary

This study tests a one-time gene therapy (DTX301) for adults with late-onset OTC deficiency, a genetic disorder that causes dangerous ammonia buildup in the blood. The goal is to safely keep ammonia levels normal without long-term medication. About 32 participants will receive either the gene therapy or a placebo, and researchers will monitor ammonia levels and crisis events over time.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Centro Hospitalar Universitario de Sao Joao

    Porto, 4200-319, Portugal

  • Clinica Universitaria Reina Fabiola

    Córdoba, X5004, Argentina

  • Erasmus Universitair Medisch Centrum Rotterrdam

    Rotterdam, 3015, Netherlands

  • Fujita Health University Hospital

    Toyoake, 470-1192, Japan

  • Fundacio Hospital Universitari Vall D'Hebron-Institute de Recerca

    Barcelona, 08035, Spain

  • Hopital Femme Mere Enfant

    Bron, 69500, France

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199, Argentina

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903, Brazil

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Necker-Enfants Maladas Hospital

    Paris, 75015, France

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California

    Los Angeles, California, 90095, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

Conditions

Explore the condition pages connected to this study.