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Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

NCT ID: NCT06605378

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-18

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Granulomatous Disease (CGD)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ensoma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Home-based telemedicine

Montgomery, Alabama, United States

Site Status RECRUITING

Home-based telemedicine

Phoenix, Arizona, United States

Site Status RECRUITING

Home-based telemedicine

Little Rock, Arkansas, United States

Site Status RECRUITING

Home-based telemedicine

Sacramento, California, United States

Site Status RECRUITING

University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Home-based telemedicine

Denver, Colorado, United States

Site Status RECRUITING

Home-based telemedicine

Hartford, Connecticut, United States

Site Status RECRUITING

Home-based telemedicine

Dover, Delaware, United States

Site Status RECRUITING

Home-based telemedicine

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Home-based telemedicine

Tallahassee, Florida, United States

Site Status RECRUITING

Home-based telemedicine

Atlanta, Georgia, United States

Site Status RECRUITING

Home-based telemedicine

Boise, Idaho, United States

Site Status RECRUITING

Home-based telemedicine

Springfield, Illinois, United States

Site Status RECRUITING

Home-based telemedicine

Indianapolis, Indiana, United States

Site Status RECRUITING

Home-based telemedicine

Des Moines, Iowa, United States

Site Status RECRUITING

Home-based telemedicine

Topeka, Kansas, United States

Site Status RECRUITING

Home-based telemedicine

Frankfort, Kentucky, United States

Site Status RECRUITING

Home-based telemedicine

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Home-based telemedicine

Augusta, Maine, United States

Site Status RECRUITING

Home-based telemedicine

Annapolis, Maryland, United States

Site Status RECRUITING

Home-based telemedicine

Boston, Massachusetts, United States

Site Status RECRUITING

Home-based telemedicine

Lansing, Michigan, United States

Site Status RECRUITING

Home-based telemedicine

Saint Paul, Minnesota, United States

Site Status RECRUITING

Home-based telemedicine

Jackson, Mississippi, United States

Site Status RECRUITING

Home-based telemedicine

Jefferson City, Missouri, United States

Site Status RECRUITING

Home-based telemedicine

Helena, Montana, United States

Site Status RECRUITING

Home-based telemedicine

Lincoln, Nebraska, United States

Site Status RECRUITING

Home-based telemedicine

Carson City, Nevada, United States

Site Status RECRUITING

Home-based telemedicine

Concord, New Hampshire, United States

Site Status RECRUITING

Home-based telemedicine

Trenton, New Jersey, United States

Site Status RECRUITING

Home-based telemedicine

Santa Fe, New Mexico, United States

Site Status RECRUITING

Home-based telemedicine

Albany, New York, United States

Site Status RECRUITING

Science 37, Inc

Morrisville, North Carolina, United States

Site Status RECRUITING

Home-based telemedicine

Bismarck, North Dakota, United States

Site Status RECRUITING

Home-based telemedicine

Columbus, Ohio, United States

Site Status RECRUITING

Home-based telemedicine

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Home-based telemedicine

Salem, Oregon, United States

Site Status RECRUITING

Home-based telemedicine

Harrisburg, Pennsylvania, United States

Site Status RECRUITING

Home-based telemedicine

Providence, Rhode Island, United States

Site Status RECRUITING

Home-based telemedicine

Columbia, South Carolina, United States

Site Status RECRUITING

Home-based telemedicine

Pierre, South Dakota, United States

Site Status RECRUITING

Home-based telemedicine

Nashville, Tennessee, United States

Site Status RECRUITING

Home-based telemedicine

Austin, Texas, United States

Site Status RECRUITING

Home-based telemedicine

Salt Lake City, Utah, United States

Site Status RECRUITING

Home-based telemedicine

Montpelier, Vermont, United States

Site Status RECRUITING

Home-based telemedicine

Richmond, Virginia, United States

Site Status RECRUITING

Home-based telemedicine

Olympia, Washington, United States

Site Status RECRUITING

Home-based telemedicine

Charleston, West Virginia, United States

Site Status RECRUITING

Home-based telemedicine

Madison, Wisconsin, United States

Site Status RECRUITING

Home-based telemedicine

Cheyenne, Wyoming, United States

Site Status RECRUITING

Great Ormond Street Hospital for Children

London, , United Kingdom

Site Status COMPLETED

Royal Free London NHS Foundation Trust

London, , United Kingdom

Site Status COMPLETED

Countries

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United States United Kingdom

Central Contacts

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Andrew Dietz, MD, MSCR

Role: CONTACT

[email protected]
617-766-3917

Facility Contacts

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Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Kathy Nguyen, CCRP

Role: primary

[email protected]
415-476-6997

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Study Director

Role: primary

[email protected]
984-314-2276

Other Identifiers

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EN-374-100

Identifier Type: -

Identifier Source: org_study_id

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