One-Time gene therapy could free PKU patients from strict diet

NCT ID NCT05972629

First seen Nov 01, 2025 · Last updated May 16, 2026 · Updated 27 times

Summary

This study tests a one-time gene therapy (SAR444836) for adults with phenylketonuria (PKU), a genetic disorder that makes it hard to break down an amino acid called phenylalanine (Phe). The goal is to lower Phe levels in the blood and allow participants to eat a normal diet without strict restrictions. About 32 adults will receive the treatment and be followed for at least 5 years to check safety and effectiveness.

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Contacts and locations

Locations

  • Children's Hospital IMD Clinic- Site Number : 8400015

    Aurora, Colorado, 80045, United States

  • Hospital de Clinicas de Porto Alegre - HCPA- Site Number : 0760001

    Porto Alegre, Rio Grande do Sul, 90035903, Brazil

  • Investigational Site Number : 0320002

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1199, Argentina

  • Investigational Site Number : 3760001

    Tel Litwinsky, 52621, Israel

  • Investigational Site Number : 7920001

    Ankara, 06560, Turkey (Türkiye)

  • Medical University of SC- Site Number : 8400004

    Charleston, South Carolina, 29425, United States

  • UHCMC- Site Number : 8400014

    Cleveland, Ohio, 44106, United States

  • UPMC Children's Hospital of Pittsburgh-4401 Penn Ave- Site Number : 8400018

    Pittsburgh, Pennsylvania, 15224-1334, United States

  • University of California San Francisco- Site Number : 8400007

    San Francisco, California, 94143, United States

  • University of Florida-Genetics- Site Number : 8400010

    Gainesville, Florida, 32610, United States

  • University of Texas- Site Number : 8400002

    Houston, Texas, 77030, United States

Conditions

Explore the condition pages connected to this study.