Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

Ensoma

Status: Enrolling

Conditions: Chronic Granulomatous Disease (CGD)

Study type: Observational

Funder types: Industry

Identifiers

NCT06605378

EN-374-100

Details and patient eligibility

About

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

Full 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 characterize the prevalence of these markers in this population.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.