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

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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

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.
    

Study Phase

Phase 1

Study Type

Interventional




Condition

Vasculitis

Intervention

Interleukin-10


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

15

Start Date

February 1998

Completion Date

April 2000


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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00001761

Organization ID

980059

Secondary IDs

98-I-0059


Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)


Study Sponsor

, , 


Verification Date

January 1999