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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00001317 |
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Date of registration:
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03/11/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood
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Scientific title:
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A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood |
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Date of first enrolment:
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May 1992 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00001317 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Granulomatous Disease
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Intervention(s)
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Drug: interferon-gamma
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Secondary ID(s)
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92-I-0186
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920186
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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