Chronic Granulomatous Disease Clinical Trial
Official title:
A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood
In a recent double-blinded, placebo-controlled multi-center international study,
subcutaneous injections of interferon-gamma administered three times weekly reduced the
frequency of serious infections in patients with chronic granulomatous disease. Patients
receiving interferon-gamma had fewer hospital stays, shorter in length, than the placebo
group. Children less than 10 years of age benefitted most from treatment and had fewer side
effects.
Based on these data, the FDA licensed interferon-gamma for prophylaxis in CGD patients. We
wish to monitor our patients who participated in the original study for possible long-term
side effects. Any new patients referred to us who are either on interferon-gamma or
considered to be candidates for interferon-gamma will be considered for this protocol. In
addition, our patients who were originally accepted under Genentech's compassionate plea
protocol will also be monitored under this new protocol. The patients will be evaluated
every six months, with blood work and interim medical histories taken.
In a recent double-blinded, placebo-controlled multi-center international study,
subcutaneous injections of interferon-gamma administered three times weekly reduced the
frequency of serious infections in patients with chronic granulomatous disease. Patients
receiving interferon-gamma had fewer hospital stays, shorter in length, than the placebo
group. Children less than 10 years of age benefitted most from treatment and had fewer side
effects.
Based on these data, the FDA licensed interferon-gamma for prophylaxis in CGD patients. We
wish to monitor our patients who participated in the original study for possible long-term
side effects. Any new patients referred to us who are either on interferon-gamma or
considered to be candidates for interferon-gamma will be considered for this protocol. In
addition, our patients who were originally accepted under Genentech's compassionate plea
protocol will also be monitored under this new protocol. The patients will be evaluated
every six months, with blood work and interim medical histories taken.
;
Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03278912 -
Natural History of Intestinal Inflammation in People With Primary Immune Dysregulations
|
||
| Recruiting |
NCT01652092 -
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies
|
N/A | |
| Completed |
NCT04136028 -
IL-1 Receptor Inhibitor for Granulomatous Complications in Patients With Chronic Granulomatous Disease
|
Early Phase 1 | |
| Recruiting |
NCT05687474 -
Baby Detect : Genomic Newborn Screening
|
||
| Terminated |
NCT03080480 -
Pioglitazone Therapy for Chronic Granulomatous Disease
|
Phase 1/Phase 2 | |
| Terminated |
NCT00394316 -
Gene Therapy for Chronic Granulomatous Disease
|
Early Phase 1 | |
| Recruiting |
NCT03910452 -
Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide
|
Early Phase 1 | |
| Terminated |
NCT02282904 -
Haploidentical Transplant for People With Chronic Granulomatous Disease Using Post Transplant Cyclophosphamide
|
Phase 1/Phase 2 | |
| Terminated |
NCT02926963 -
Generation of Powerful Biological Tools for Understanding the Pathophysiology of Chronic Granulomatous Disease.
|
N/A | |
| Completed |
NCT00006417 -
Modified Stem Cell Transplantation Procedure for Treating Chronic Granulomatous Disease
|
Phase 2 | |
| Completed |
NCT00368446 -
Genetic Disorders of Mucociliary Clearance in Nontuberculous Mycobacterial Lung Disease
|
||
| Enrolling by invitation |
NCT03655223 -
Early Check: Expanded Screening in Newborns
|
||
| Recruiting |
NCT06162936 -
Neutrophil Oxidative Burst in Early and Late Onset Pediatric Inflammatory Bowel Disease
|
||
| Terminated |
NCT05915897 -
Whole Blood Biospecimen Collection for Subjects With Chronic Granulomatous Disease (CGD)
|
||
| Terminated |
NCT00325078 -
Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT03548818 -
Role of Interferon-gamma 1-b (IFN-γ) on Cells of the Innate Immune System: Functional, Biochemical and Gene Expression Studies in Patients With Chronic Granulomatous Disease
|
||
| Recruiting |
NCT01821781 -
Immune Disorder HSCT Protocol
|
Phase 2 | |
| Completed |
NCT00578643 -
Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease
|
Phase 2 | |
| Terminated |
NCT00006054 -
Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
|
N/A | |
| Enrolling by invitation |
NCT06253507 -
pCCLCHIM-p47 (Lentiviral Vector Transduced CD34 Plus Cells) in Patients With p47 Autosomal Recessive Chronic Granulomatous Disease (AR-CGD)
|
Phase 1/Phase 2 |