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Recruiting

NCT Number: NCT06605378

Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

This research study is designed to assess the prevalence of specific antibodies and inflammatory cytokines in adult and pediatric participants with CGD.

Recruiting

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Key information

About this study

In this observational study, blood samples will be collected from adult and pediatric patients with CGD. The level of circulating adenovirus antibodies and inflammatory cytokines will be measured to characterize the prevalence of these markers in this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The participant must have been diagnosed with CGD based on the referring physician's confirmation that NADPH oxidase activity is ≤5% (i.e., the percentage of dihydrorhodamine-positive [DHR+] cells is ≤5% by flow cytometry) OR based on confirmed pathogenic mutation in a CGD associated gene (CYBB, CYBA, NCF1, NCF2, NCF4, or CYBC1).
  • The participant or the participant's legally authorized guardian or representative (if applicable) must be capable of giving signed informed consent.
  • The participant (with assistance from the participant's legally authorized guardian/representative or primary caregiver, if applicable) must be capable of complying with the requirements and restrictions listed in the protocol and informed consent form (ICF).

Exclusion criteria

  • The participant has undergone an allogeneic bone marrow transplant or investigational gene therapy.
  • The participant is unable to comply with the sample collection procedure based on investigator judgment.

Treatment and study plan

Primary outcomes

  1. Total adenoviral-specific antibody (TAb) titer

    Time frame: 1 Day

    Level of total adenoviral-specific antibody in blood

  2. Adenoviral-specific neutralizing antibody (NAb) titer

    Time frame: 1 Day

    Level of adenoviral-specific neutralizing antibodies in blood

Secondary outcomes

  1. Circulating inflammatory cytokine levels

    Time frame: 1 Day

    Level of inflammatory cytokines in blood

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Dietz, MD, MSCR

CONTACT

[email protected]

617-766-3917

Sponsors and collaborators

Lead sponsor

Ensoma

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 20, 2024
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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