RecruitingNCT06605378
Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease
A Cross-Sectional, Observational Study of the Prevalence of Adenoviral-Specific Antibodies and Inflammatory Cytokines in Participants With Chronic Granulomatous Disease
Sponsor
Ensoma
Enrollment
60 participants
Start Date
Nov 18, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
This research study is designed to assess the prevalence of specific antibodies and inflammatory cytokines in adult and pediatric participants with CGD.
Eligibility
Inclusion Criteria3
- 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 Criteria2
- 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.
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Locations(52)
View Full Details on ClinicalTrials.gov
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NCT06605378