Analysis of Patients Treated for Chronic Granulomatous Disease Since January 1, 1995
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ClinicalTrials.gov Identifier: NCT02116764 |
Recruitment Status :
Enrolling by invitation
First Posted : April 17, 2014
Last Update Posted : March 24, 2021
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Condition or disease |
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Chronic Granulomatous Disease |
Study Type : | Observational |
Actual Enrollment : | 137 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Analysis of Patients Treated for Chronic Granulomatous Disease Since January 1, 1995 |
Actual Study Start Date : | June 11, 2014 |
Estimated Primary Completion Date : | December 1, 2022 |
Estimated Study Completion Date : | December 1, 2022 |

Group/Cohort |
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Cross Sectional
3 years after Transplant
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No Transplant
These patients were diagnosed with CGD but have not been transplanted
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Prospective
Prior to Transplant Conditioning
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Retrospective
1 year after Transplant
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- The primary objective of this protocol is to estimate the 1- year, 2-year and 3-year (and longer if possible) overall survival probabilities post-HCT of CGD subjects born on or after 1988 who receive HCTon or after 1995. [ Time Frame: 1, 2 or 3 year ]Clinical outcomes (survival, infection, autoimmune disease, chimerism, GVHD)
- To compare overall survival from birth between patients born on or after 1988 who receive HCT on or after 1995 vs. those born on or after 1988 who receive conventional therapy, after adjusting for differences in year of birth and oxidase acti... [ Time Frame: 3 years post Transplant or Non Transplant ]Clinical outcomes (survival, infection, autoimmune disease, chimerism, GVHD)

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Ages Eligible for Study: | 3 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
- Both HCT and non-HCT subjects must be over the age of 2 and actively enrolled and receiving treatment under a CGD protocol at NIAID.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116764
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Principal Investigator: | Elizabeth M Kang, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT02116764 |
Other Study ID Numbers: |
140091 14-I-0091 |
First Posted: | April 17, 2014 Key Record Dates |
Last Update Posted: | March 24, 2021 |
Last Verified: | November 10, 2020 |
Rare Diseases Primary Immune Deficiency Treatment Consortium Retrospective |
Granuloma Granulomatous Disease, Chronic Lymphoproliferative Disorders Lymphatic Diseases Pathologic Processes Phagocyte Bactericidal Dysfunction |
Leukocyte Disorders Hematologic Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn Immunologic Deficiency Syndromes Immune System Diseases |