search
Back to results

Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's Granulomatosis

Primary Purpose

Vasculitis, Wegener's Granulomatosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interleukin-10
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasculitis focused on measuring Autoimmunity, Cytokine, Inflammation, Interleukin, Vasculitis, Wegener's Granulomatosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Diagnosis of Wegener's granulomatosis based on clinical characteristics and histopathological and/or angiographic evidence of vasculitis or the presence of glomerulonephritis and a positive assay for anti-neutrophil cytoplasmic autoantibodies (ANCA). Age between 18 to 65 years. No change in immunosuppressive drug therapy during the prior 4 weeks and one of the following: Persistent disease activity ("Vasculitis Activity Index" score of greater than or equal to 3) despite optimal therapy; Persistent or recurrent disease activity in a patient who cannot tolerate optimal therapy; Patients not on maximal immunosuppressive therapy but with persistent or recurrent disease activity that is not, in the judgment of investigators, immediately threatening the function of a major organ system; No evidence of active infection. Patients may not be pregnant or nursing infants. Fertile women must have a negative pregnancy test within one week prior to study entry and all participants must be using effective means of birth control. Serum creatinine is less than 3.5 mg/dL. Hemocytopenia (platelet count is greater than 100,000/mm(3), leukocyte count is greater than 3,500/mm(s), hemoglobin is greater than 9 mg/dL). Liver function test abnormalities is less than 3x upper limits of normal (either serum GOT, GPT, alkaline phosphatase, and/or bilirubin). Patients cannot be anti-HIV, anti-HCV, or anti-Hepatitis B surface antigen (HBsAG) positive. Weight greater less than 104 Kg (because of SCH 52000 concentration and volume limitations for subcutaneous injection). No treatment with any investigational drug within 30 days. No pre-existing malignancy. No known allergy to E. coli protein or IL-10. No history of psychiatric illness that in the opinion of the principal investigator would preclude entrance into the study.

Sites / Locations

  • National Institute of Allergy and Infectious Diseases (NIAID)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001761
Brief Title
Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's Granulomatosis
Official Title
Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's Granulomatosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 1999
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the safety, tolerance, and immunologic effects of interleukin-10 (IL-10), in patients with Wegener's granulomatosis. A secondary objective is to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of Wegener's granulomatosis to warrant further study in a larger trial. In this study, IL-10 will be given either alone or in combination with standard therapeutic agents, usually consisting of cyclophosphamide, methotrexate, and/or prednisone. Patients will be eligible to receive IL-10 when there is evidence of active disease. IL-10 will be administered by subcutaneous injection at a dose of 4 µ (Micro)g/kg/day for 28 days.
Detailed Description
The purpose of the study is to assess the safety, tolerance, and immunologic effects of interleukin-10 (IL-10), in patients with Wegener's granulomatosis. A secondary objective is to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of Wegener's granulomatosis to warrant further study in a larger trial. In this study, IL-10 will be given either alone or in combination with standard therapeutic agents, usually consisting of cyclophosphamide, methotrexate, and/or prednisone. Patients will be eligible to receive IL-10 when there is evidence of active disease. IL-10 will be administered by subcutaneous injection at a dose of 4 µ (Micro)g/kg/day for 28 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasculitis, Wegener's Granulomatosis
Keywords
Autoimmunity, Cytokine, Inflammation, Interleukin, Vasculitis, Wegener's Granulomatosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interleukin-10

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Diagnosis of Wegener's granulomatosis based on clinical characteristics and histopathological and/or angiographic evidence of vasculitis or the presence of glomerulonephritis and a positive assay for anti-neutrophil cytoplasmic autoantibodies (ANCA). Age between 18 to 65 years. No change in immunosuppressive drug therapy during the prior 4 weeks and one of the following: Persistent disease activity ("Vasculitis Activity Index" score of greater than or equal to 3) despite optimal therapy; Persistent or recurrent disease activity in a patient who cannot tolerate optimal therapy; Patients not on maximal immunosuppressive therapy but with persistent or recurrent disease activity that is not, in the judgment of investigators, immediately threatening the function of a major organ system; No evidence of active infection. Patients may not be pregnant or nursing infants. Fertile women must have a negative pregnancy test within one week prior to study entry and all participants must be using effective means of birth control. Serum creatinine is less than 3.5 mg/dL. Hemocytopenia (platelet count is greater than 100,000/mm(3), leukocyte count is greater than 3,500/mm(s), hemoglobin is greater than 9 mg/dL). Liver function test abnormalities is less than 3x upper limits of normal (either serum GOT, GPT, alkaline phosphatase, and/or bilirubin). Patients cannot be anti-HIV, anti-HCV, or anti-Hepatitis B surface antigen (HBsAG) positive. Weight greater less than 104 Kg (because of SCH 52000 concentration and volume limitations for subcutaneous injection). No treatment with any investigational drug within 30 days. No pre-existing malignancy. No known allergy to E. coli protein or IL-10. No history of psychiatric illness that in the opinion of the principal investigator would preclude entrance into the study.
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
1739240
Citation
Hoffman GS, Kerr GS, Leavitt RY, Hallahan CW, Lebovics RS, Travis WD, Rottem M, Fauci AS. Wegener granulomatosis: an analysis of 158 patients. Ann Intern Med. 1992 Mar 15;116(6):488-98. doi: 10.7326/0003-4819-116-6-488.
Results Reference
background
PubMed Identifier
9531324
Citation
Ludviksson BR, Sneller MC, Chua KS, Talar-Williams C, Langford CA, Ehrhardt RO, Fauci AS, Strober W. Active Wegener's granulomatosis is associated with HLA-DR+ CD4+ T cells exhibiting an unbalanced Th1-type T cell cytokine pattern: reversal with IL-10. J Immunol. 1998 Apr 1;160(7):3602-9.
Results Reference
background

Learn more about this trial

Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's Granulomatosis

We'll reach out to this number within 24 hrs