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Home > "A" Clinical Trials Conditions > A Phase IV Study of Recombinant Human Gamma Interferon in Patients with Chronic Granulomatous Diseases of Childhood  A Phase IV Study of Recombinant Human Gamma Interferon in Patients with Chronic Granulomatous Diseases of Childhood
A Phase IV Study of Recombinant Human Gamma Interferon in Patients with Chronic Granulomatous Diseases of Childhood
For Condition: Chronic Granulomatous Disease
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: The diagnosis of chronic granulomatous disease as indicated by an unusual pattern of infection in the patient or one pedigree relation, confirmed by both of the following tests: Abnormal neutrophil NBT slide test (following PMA stimulation) and neutrophil superoxide anion production less than or equal to 20 percent normal. Preserved renal function (creatinine less than or equal to 2.0 mg/100 mL; less than or equal to 2+ proteinuria). Preserved hepatic function (bilirubin less than or equal to 1.5 mg/100 mL; prothrombin time less than or equal to 1.3 x control). Preserved hematologic function (WBC greater than or equal to 3000/mm3; granulocytes greater than 1500/mm3; platelets greater than or equal to 100,000/mm3). A minimum life expectancy of three months. Patients seropositive for Hepatitis B surface antigen may be entered but serum specimens for rIFN-y antibody should not be collected. Patients must not be pregnant or lactating. Patients of childbearing potential may be entered if using effective contraception. Full recovery from previous serious infections requiring hospitalization and parenteral antibiotic therapy. At least two weeks must elapse following the cessation of parenteral antibiotic therapy before study admission.
Total Enrollment: 100
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 920186; 92-I-0186
Study Start Date: May 10, 1992
Record last reviewed: May 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001317
Other Chronic Granulomatous Disease Studies:
1. Use of G-CSF to Obtain Blood Cell Precursors
2. Learning and Behavior Problems in Children with Chronic Granulomatous Disease and Related Disorders
3. Treatment of Chronic Granulomatous Disease with Allogeneic Stem Cell Transplantation versus Standard of Care
4. Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
5. Stem Cell Transplant Following Low-Intensity Chemotherapy to Treat Chronic Granulomatous Disease
Related Studies:
Other Chronic Granulomatous Disease Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Phase IV Study of Recombinant Human Gamma Interferon in Patients with Chronic Granulomatous Diseases of Childhood
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