A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Granulomatous Disease
Intervention: interferon-gamma (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
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.
Clinical Details
Official title: A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood
Study design: Treatment
Detailed description:
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, Maryland 20892, United States
Additional Information
Related publications: Ross JP, Holland SM, Gill VJ, DeCarlo ES, Gallin JI. Severe Burkholderia (Pseudomonas) gladioli infection in chronic granulomatous disease: report of two successfully treated cases. Clin Infect Dis. 1995 Nov;21(5):1291-3. Gallin JI, Farber JM, Holland SM, Nutman TB. Interferon-gamma in the management of infectious diseases. Ann Intern Med. 1995 Aug 1;123(3):216-24. Review.
Starting date: May 1992
Ending date: July 2001
Last updated: March 3, 2008
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