Recruiting

Observational Study

Sponsor:

Ensoma

Code:

NCT06605378

Conditions

Chronic Granulomatous Disease (CGD)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Chronic Granulomatous Disease (CGD)

Study ID

NCT06605378

Start date

Nov 18, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Total adenoviral-specific antibody (TAb) titer [ Time Frame: 1 Day ]
  • Adenoviral-specific neutralizing antibody (NAb) titer [ Time Frame: 1 Day ]

Central Contacts and Locations

Central contacts

Andrew Dietz, MD, MSCR

617-766-3917ddietz@ensoma.com

Locations

Home-based telemedicine

Recruiting

Montgomery, Alabama, United States, 36104

Contacts

Home-based telemedicine

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Phoenix, Arizona, United States, 85001

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Home-based telemedicine

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Little Rock, Arkansas, United States, 72201

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Home-based telemedicine

Recruiting

Sacramento, California, United States, 95814

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University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Principal Investigator:

Morna Dorsey, MD

Home-based telemedicine

Recruiting

Denver, Colorado, United States, 80202

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Hartford, Connecticut, United States, 06103

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Dover, Delaware, United States, 19901

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Washington D.C., District of Columbia, United States, 20001

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Tallahassee, Florida, United States, 32301

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Atlanta, Georgia, United States, 30303

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Boise, Idaho, United States, 83702

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Springfield, Illinois, United States, 62701

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Indianapolis, Indiana, United States, 46225

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Des Moines, Iowa, United States, 50309

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Topeka, Kansas, United States, 66603

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Frankfort, Kentucky, United States, 40601

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Baton Rouge, Louisiana, United States, 70802

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Augusta, Maine, United States, 04330

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Annapolis, Maryland, United States, 21401

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Boston, Massachusetts, United States, 02210

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Lansing, Michigan, United States, 48933

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Saint Paul, Minnesota, United States, 55102

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Jackson, Mississippi, United States, 39205

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Jefferson City, Missouri, United States, 65101

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Helena, Montana, United States, 59623

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Lincoln, Nebraska, United States, 68502

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Carson City, Nevada, United States, 89701

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Concord, New Hampshire, United States, 03301

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Trenton, New Jersey, United States, 08608

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Santa Fe, New Mexico, United States, 87501

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Home-based telemedicine

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Albany, New York, United States, 12207

Contacts

Science 37, Inc

Recruiting

Morrisville, North Carolina, United States, 27560

Contacts

Home-based telemedicine

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Bismarck, North Dakota, United States, 58501

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Columbus, Ohio, United States, 43215

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Oklahoma City, Oklahoma, United States, 73102

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Salem, Oregon, United States, 97301

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Harrisburg, Pennsylvania, United States, 17101

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Providence, Rhode Island, United States, 02903

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Columbia, South Carolina, United States, 29217

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Pierre, South Dakota, United States, 57501

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Nashville, Tennessee, United States, 37219

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Austin, Texas, United States, 78701

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Salt Lake City, Utah, United States, 84111

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Montpelier, Vermont, United States, 05602

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Home-based telemedicine

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Richmond, Virginia, United States, 23219

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Home-based telemedicine

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Olympia, Washington, United States, 98507

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Home-based telemedicine

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Charleston, West Virginia, United States, 25301

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Home-based telemedicine

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Madison, Wisconsin, United States, 53703

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Home-based telemedicine

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Cheyenne, Wyoming, United States, 82001

Contacts

More Information

Sponsor

Ensoma

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • CGD
  • X-CGD
  • Chronic Granulomatous Disease
  • Granulomatous Disease, Chronic
  • Autosomal Recessive Chronic Granulomatous Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Ensoma on 2026-08-17.