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
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