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

Chronic Granulomatous Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001317
• Other study ID #: 920186
• Secondary ID: 92-I-0186
• Status: Completed
• Phase: Phase 4
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: May 1992
• Est. completion date: July 2001

Study information

• Verified date: May 2000
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Granulomatous Disease
• Granuloma
• Granulomatous Disease, Chronic

Intervention

Drug:
• interferon-gamma

Locations

Country	Name	City	State
United States	National Institute of Allergy and Infectious Diseases (NIAID)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation