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Chronic Granulomatous Disease (CGD)NCT06605378

Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

An observational study of Chronic Granulomatous Disease (CGD), run by Ensoma at 52 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Any age
Conditions the study is for
Chronic Granulomatous Disease (CGD)
How many people
60 participants
Where
52 sitesin 2 countries
Study dates
18 Nov 2024to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: People with CGD

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

52 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Andrew Dietz, MD, MSCR contact

617-766-3917

ddietz@ensoma.com

52 sites in 2 countries

United States50 sites, 50 recruiting

  • Home-based telemedicine

    Albany, New York, 12207

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Annapolis, Maryland, 21401

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Atlanta, Georgia, 30303

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Augusta, Maine, 04330

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Austin, Texas, 78701

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Baton Rouge, Louisiana, 70802

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Bismarck, North Dakota, 58501

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Boise, Idaho, 83702

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Boston, Massachusetts, 02210

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Carson City, Nevada, 89701

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Charleston, West Virginia, 25301

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Cheyenne, Wyoming, 82001

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Columbia, South Carolina, 29217

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Columbus, Ohio, 43215

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Concord, New Hampshire, 03301

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Denver, Colorado, 80202

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Des Moines, Iowa, 50309

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Dover, Delaware, 19901

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Frankfort, Kentucky, 40601

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Harrisburg, Pennsylvania, 17101

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Hartford, Connecticut, 06103

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Helena, Montana, 59623

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Indianapolis, Indiana, 46225

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Jackson, Mississippi, 39205

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Jefferson City, Missouri, 65101

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Lansing, Michigan, 48933

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Lincoln, Nebraska, 68502

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Little Rock, Arkansas, 72201

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Madison, Wisconsin, 53703

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Montgomery, Alabama, 36104

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Montpelier, Vermont, 05602

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Science 37, Inc

    Morrisville, North Carolina, 27560

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Nashville, Tennessee, 37219

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Oklahoma City, Oklahoma, 73102

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Olympia, Washington, 98507

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Phoenix, Arizona, 85001

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Pierre, South Dakota, 57501

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Providence, Rhode Island, 02903

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Richmond, Virginia, 23219

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Sacramento, California, 95814

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Saint Paul, Minnesota, 55102

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Salem, Oregon, 97301

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Salt Lake City, Utah, 84111

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94158

    Kathy Nguyen, CCRP, 415-476-6997, Kathy.Nguyen3@ucsf.edu

    Morna Dorsey, MD

    Recruiting

  • Home-based telemedicine

    Santa Fe, New Mexico, 87501

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Springfield, Illinois, 62701

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Tallahassee, Florida, 32301

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Topeka, Kansas, 66603

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Trenton, New Jersey, 08608

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

  • Home-based telemedicine

    Washington D.C., District of Columbia, 20001

    Study Director, 984-314-2276, Ensoma_CGD@Science37.com

    Recruiting

Other trials in United States

United Kingdom2 sites

  • Great Ormond Street Hospital for Children

    London, WC1N 3JH

    Completed

  • Royal Free London NHS Foundation Trust

    London

    Completed

Other trials in United Kingdom

About this study

Official title: A Cross-Sectional, Observational Study of the Prevalence of Adenoviral-Specific Antibodies and Inflammatory Cytokines in Participants With Chronic Granulomatous Disease

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

Read the detailed description

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.

Keywords
CGD, X-CGD, Chronic Granulomatous Disease, Granulomatous Disease, Chronic, Autosomal Recessive Chronic Granulomatous Disease
Medical subject headings
Granulomatous Disease, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total adenoviral-specific antibody (TAb) titer

    Level of total adenoviral-specific antibody in blood

    Measured: 1 Day

  2. Adenoviral-specific neutralizing antibody (NAb) titer

    Level of adenoviral-specific neutralizing antibodies in blood

    Measured: 1 Day

Secondary outcomes (1)

  1. Circulating inflammatory cytokine levels

    Level of inflammatory cytokines in blood

    Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2024
  2. Study start18 Nov 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06605378
Sponsor's protocol ID
EN-374-100
Status last verified
Aug 2026
First submitted
10 Sep 2024
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Morna Dorsey, Claire Booth, Jonathan Cotliar, Esther Shamir, Mansi Purwar, Patrick Au, Chris Plescia, Andrew Dietz, Siobhan Burns; Cytokine Profile in Patients with Chronic Granulomatous Disease (CGD). J Hum Immun 1 May 2026; 2 (CIS2026): eCIS2026abstract.45. doi: https://doi.org/10.70962/CIS2026abstract.45

  • Claire Booth, Morna Dorsey, Jonathan Cotliar, Esther Shamir, Patrick Au, Chris Plescia, Siobhan Burns, Andrew Dietz; Preexisting Antibodies to Virus-Like Particles (VLP) Derived from Helper-Dependent Adenovirus (HDAd) in Patients with Chronic Granulomatous Disease (CGD). J Hum Immun 1 May 2026; 2 (CIS2026): eCIS2026abstract.88. doi: https://doi.org/10.70962/CIS2026abstract.88

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Granulomatous Disease (CGD), run by Ensoma at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrew Dietz, MD, MSCR (617-766-3917, ddietz@ensoma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total adenoviral-specific antibody (TAb) titer (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06605378, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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