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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001761
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: January 1999
  Purpose

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.


Condition Intervention Phase
Vasculitis
Wegener's Granulomatosis
Drug: Interleukin-10
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's Granulomatosis

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 15
Study Start Date: February 1998
Estimated Study Completion Date: April 2000
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001761

Locations
United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001761     History of Changes
Other Study ID Numbers: 980059, 98-I-0059
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Autoimmunity
Cytokine
Inflammation
Interleukin
Vasculitis
Wegener's Granulomatosis

Additional relevant MeSH terms:
Wegener Granulomatosis
Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Cardiovascular Diseases
Immune System Diseases
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Systemic Vasculitis
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014