Nctid:
NCT00001761
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000014890", "term"=>"Granulomatosis with Polyangiitis"}, {"id"=>"D000014657", "term"=>"Vasculitis"}], "ancestors"=>[{"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000017563", "term"=>"Lung Diseases, Interstitial"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000056648", "term"=>"Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis"}, {"id"=>"D000056647", "term"=>"Systemic Vasculitis"}, {"id"=>"D000017445", "term"=>"Skin Diseases, Vascular"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}, {"id"=>"M17630", "name"=>"Granulomatosis with Polyangiitis", "asFound"=>"Wegener's Granulomatosis", "relevance"=>"HIGH"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M17405", "name"=>"Vasculitis", "asFound"=>"Vasculitis", "relevance"=>"HIGH"}, {"id"=>"M28526", "name"=>"Systemic Vasculitis", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M19813", "name"=>"Lung Diseases, Interstitial", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M28527", "name"=>"Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M19714", "name"=>"Skin Diseases, Vascular", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"T2610", "name"=>"Granulomatosis With Polyangiitis", "asFound"=>"Wegener's Granulomatosis", "relevance"=>"HIGH"}, {"id"=>"T375", "name"=>"ANCA-associated Vasculitis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>15}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1998-02"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-01", "completionDateStruct"=>{"date"=>"2000-04"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Autoimmunity", "Cytokine", "Inflammation", "Interleukin", "Vasculitis", "Wegener's Granulomatosis"], "conditions"=>["Vasculitis", "Wegener's Granulomatosis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"1739240", "type"=>"BACKGROUND", "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."}, {"pmid"=>"9531324", "type"=>"BACKGROUND", "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."}]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"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).\n\nAge between 18 to 65 years.\n\nNo change in immunosuppressive drug therapy during the prior 4 weeks and one of the following:\n\nPersistent disease activity (\"Vasculitis Activity Index\" score of greater than or equal to 3) despite optimal therapy;\n\nPersistent or recurrent disease activity in a patient who cannot tolerate optimal therapy;\n\nPatients 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;\n\nNo evidence of active infection.\n\nPatients 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.\n\nSerum creatinine is less than 3.5 mg/dL.\n\nHemocytopenia (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).\n\nLiver function test abnormalities is less than 3x upper limits of normal (either serum GOT, GPT, alkaline phosphatase, and/or bilirubin).\n\nPatients cannot be anti-HIV, anti-HCV, or anti-Hepatitis B surface antigen (HBsAG) positive.\n\nWeight greater less than 104 Kg (because of SCH 52000 concentration and volume limitations for subcutaneous injection).\n\nNo treatment with any investigational drug within 30 days.\n\nNo pre-existing malignancy.\n\nNo known allergy to E. coli protein or IL-10.\n\nNo history of psychiatric illness that in the opinion of the principal investigator would preclude entrance into the study."}, "identificationModule"=>{"nctId"=>"NCT00001761", "briefTitle"=>"Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's Granulomatosis", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's Granulomatosis", "orgStudyIdInfo"=>{"id"=>"980059"}, "secondaryIdInfos"=>[{"id"=>"98-I-0059"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Interleukin-10", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}}}}