Seroprevalence in Patients with Chronic Granulomatous Disease

  • Research type

    Research Study

  • Full title

    A Cross-Sectional, Observational Study of the Prevalence of Adenoviral-Specific Antibodies and Inflammatory Cytokines in Participants with Chronic Granulomatous Disease

  • IRAS ID

    348455

  • Contact name

    Claire Booth

  • Contact email

    claire.booth@gosh.nhs.uk

  • Sponsor organisation

    Ensoma, Inc.

  • Clinicaltrials.gov Identifier

    NCT06605378

  • Duration of Study in the UK

    0 years, 3 months, 11 days

  • Research summary

    Chronic granulomatous disease (CGD) is a rare primary immune deficiency disorder. Approximately, it occurs with a frequency of 1 in 200,000 live births.

    The purpose of this study, funded by Ensoma, Inc., is to analyse antibodies and cytokines circulating in the blood. Antibodies are proteins in the human blood that protect body from invaders such as viruses. Cytokines are chemical messengers that tell cells in the human body how to behave. The data collected in this study may help to design a potential clinical trial for the investigational therapy for the treatment of CGD in the future.

    This is an observational study in male children and male adults with CGD. After obtaining informed consent, a blood sample will be collected from eligible participants during a routine on-site visit. A participant completes the study when the blood sample has been collected.

    The study is being run in the US and UK, including 2 study sites in the UK. It does not present any ethical, legal, or management issues.

  • REC name

    London - Surrey Borders Research Ethics Committee

  • REC reference

    24/PR/1263

  • Date of REC Opinion

    28 Oct 2024

  • REC opinion

    Further Information Favourable Opinion