Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

Launched by ENSOMA · Sep 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the levels of specific antibodies and inflammatory substances called cytokines in men, both adults and children, who have Chronic Granulomatous Disease (CGD). CGD is a condition that affects the immune system and makes it harder for the body to fight off certain infections. The goal of the study is to understand how common these antibodies and cytokines are in people with CGD, which could help improve future treatments.

To be eligible for this trial, participants must be male and have a confirmed diagnosis of CGD, meaning their immune system is not functioning properly. However, individuals who have received a bone marrow transplant or gene therapy are not eligible. If you or someone you know qualifies and chooses to participate, you will be asked to provide samples for testing. This trial is currently recruiting participants, so it's a great opportunity to contribute to research that may help others with CGD in the future.

Gender

ALL

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.