Status:

RECRUITING

Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

Lead Sponsor:

Ensoma

Conditions:

Chronic Granulomatous Disease (CGD)

Eligibility:

All Genders

Brief Summary

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

Detailed Description

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 c...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 18 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06605378

Start Date

November 18 2024

End Date

December 1 2025

Last Update

October 21 2025

Active Locations (52)

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Page 1 of 13 (52 locations)

1

Home-based telemedicine

Montgomery, Alabama, United States, 36104

2

Home-based telemedicine

Phoenix, Arizona, United States, 85001

3

Home-based telemedicine

Little Rock, Arkansas, United States, 72201

4

Home-based telemedicine

Sacramento, California, United States, 95814