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Recruiting
NCT06605378
Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease
Conditions: Chronic Granulomatous Disease (CGD)
Sex: All
Healthy volunteers: No
Enrollment: 60
Sponsor: Ensoma
Location: Home-based telemedicine Montgomery Alabama
Summary
This research study is designed to assess the prevalence of specific antibodies and inflammatory cytokines in adult and pediatric participants with CGD.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06605378). StuddyBuddy aggregates publicly available trial information.