Nctid:
NCT00001155
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D014890", "term"=>"Granulomatosis with Polyangiitis"}, {"id"=>"D014657", "term"=>"Vasculitis"}], "ancestors"=>[{"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D017563", "term"=>"Lung Diseases, Interstitial"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D056648", "term"=>"Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis"}, {"id"=>"D056647", "term"=>"Systemic Vasculitis"}, {"id"=>"D017445", "term"=>"Skin Diseases, Vascular"}, {"id"=>"D012871", "term"=>"Skin Diseases"}, {"id"=>"D001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M17405", "name"=>"Vasculitis", "asFound"=>"Vasculitis", "relevance"=>"HIGH"}, {"id"=>"M9202", "name"=>"Granuloma", "relevance"=>"LOW"}, {"id"=>"M17630", "name"=>"Granulomatosis with Polyangiitis", "asFound"=>"Wegener's Granulomatosis", "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"=>"M4629", "name"=>"Autoimmune Diseases", "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"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D003520", "term"=>"Cyclophosphamide"}], "ancestors"=>[{"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019653", "term"=>"Myeloablative Agonists"}], "browseLeaves"=>[{"id"=>"M6727", "name"=>"Cyclophosphamide", "asFound"=>"Tablet", "relevance"=>"HIGH"}, {"id"=>"M14121", "name"=>"Prednisone", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>200}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1976-02"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2002-02", "completionDateStruct"=>{"date"=>"2002-02"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Vasculitis", "Prednisone", "Granuloma", "Wegener's Granulomatosis", "Cyclophosphamide", "Renal Biopsy"], "conditions"=>["Vasculitis", "Wegener's Granulomatosis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8602705", "type"=>"BACKGROUND", "citation"=>"Talar-Williams C, Hijazi YM, Walther MM, Linehan WM, Hallahan CW, Lubensky I, Kerr GS, Hoffman GS, Fauci AS, Sneller MC. Cyclophosphamide-induced cystitis and bladder cancer in patients with Wegener granulomatosis. Ann Intern Med. 1996 Mar 1;124(5):477-84. doi: 10.7326/0003-4819-124-5-199603010-00003."}, {"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."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this protocol is to continue to treat patients with Wegener's granulomatosis who have already entered the study, and to treat new patients. The investigators will attempt to correlate the clinical response with specific immunosuppressive effects of drug administration. The investigators are accumulating data on the optimal duration and side effects of therapy.", "detailedDescription"=>"The purpose of the protocol is to continue to treat patients with Wegener's granulomatosis who have already entered the study, and to treat new patients. The investigators will attempt to correlate the clinical response with specific immunosuppressive effects of drug administration. The investigators are accumulating data on the optimal duration and side effects of therapy.\n\nAge Range: greater than 1 year"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Patients greater than 1 year of age with the clinical and pathological diagnosis of WG whose illness presents a risk of permanent disability or death. Examples of processes that impart risk of permanent disability or death include: peripheral and central nervous system disease, cardiac involvement, glomerulonephritis, and vascular comprise of gastrointestinal organs.\n\nNo women who are pregnant or intend to become pregnant.\n\nNo patients who have known malignancies.\n\nPatients must be HIV negative."}, "identificationModule"=>{"nctId"=>"NCT00001155", "briefTitle"=>"Treatment of Wegener's Granulomatosis With Cyclophosphamide", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Treatment of Wegener's Granulomatosis With Cyclophosphamide", "orgStudyIdInfo"=>{"id"=>"760042"}, "secondaryIdInfos"=>[{"id"=>"76-I-0042"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"cyclophosphamide", "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"}}}}