Status:

COMPLETED

A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Chronic Granulomatous Disease

Eligibility:

All Genders

Phase:

PHASE4

Brief 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...

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...

Eligibility 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.

Key Trial Info

Start Date :

May 1 1992

Trial Type :

INTERVENTIONAL

End Date :

July 1 2001

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00001317

Start Date

May 1 1992

End Date

July 1 2001

Last Update

March 4 2008

Active Locations (1)

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1

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, United States, 20892