Back to resultsA Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood
Primary Purpose
Chronic Granulomatous Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
interferon-gamma
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Granulomatous Disease focused on measuring Children, Gamma Interferon, Hospitalizations, Infection, Chronic Granulomatous Disease
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.
Sites / Locations
- National Institute of Allergy and Infectious Diseases (NIAID)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001317
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00001317
Brief Title
A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood
Official Title
A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood
Study Type
Interventional
2. Study Status
Record Verification Date
May 2000
Overall Recruitment Status
Completed
Study Start Date
May 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Granulomatous Disease
Keywords
Children, Gamma Interferon, Hospitalizations, Infection, Chronic Granulomatous Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
interferon-gamma
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Institute of Allergy and Infectious Diseases (NIAID)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8589158
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. doi: 10.1093/clinids/21.5.1291.
Results Reference
background
PubMed Identifier
7598304
Citation
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. doi: 10.7326/0003-4819-123-3-199508010-00009.
Results Reference
background
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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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