Nctid:
NCT00000597
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000740", "term"=>"Anemia"}, {"id"=>"D000006402", "term"=>"Hematologic Diseases"}, {"id"=>"D000000741", "term"=>"Anemia, Aplastic"}, {"id"=>"D000010198", "term"=>"Pancytopenia"}], "ancestors"=>[{"id"=>"D000080983", "term"=>"Bone Marrow Failure Disorders"}, {"id"=>"D000001855", "term"=>"Bone Marrow Diseases"}, {"id"=>"D000095542", "term"=>"Cytopenia"}], "browseLeaves"=>[{"id"=>"M4070", "name"=>"Anemia", "asFound"=>"Anemia", "relevance"=>"HIGH"}, {"id"=>"M4071", "name"=>"Anemia, Aplastic", "asFound"=>"Anemia, Aplastic", "relevance"=>"HIGH"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "asFound"=>"Hematologic Diseases", "relevance"=>"HIGH"}, {"id"=>"M13118", "name"=>"Pancytopenia", "asFound"=>"Pancytopenia", "relevance"=>"HIGH"}, {"id"=>"M2241", "name"=>"Bone Marrow Failure Disorders", "relevance"=>"LOW"}, {"id"=>"M5134", "name"=>"Bone Marrow Diseases", "relevance"=>"LOW"}, {"id"=>"M3170", "name"=>"Cytopenia", "relevance"=>"LOW"}, {"id"=>"T460", "name"=>"Aplastic Anemia", "asFound"=>"Anemia, Aplastic", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077603", "term"=>"Nandrolone Decanoate"}, {"id"=>"D000009277", "term"=>"Nandrolone"}, {"id"=>"C000008580", "term"=>"Nandrolone phenpropionate"}, {"id"=>"D000000961", "term"=>"Antilymphocyte Serum"}], "ancestors"=>[{"id"=>"D000000728", "term"=>"Androgens"}, {"id"=>"D000006728", "term"=>"Hormones"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000045930", "term"=>"Anabolic Agents"}, {"id"=>"D000050071", "term"=>"Bone Density Conservation Agents"}, {"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000007166", "term"=>"Immunosuppressive Agents"}], "browseLeaves"=>[{"id"=>"M1859", "name"=>"Nandrolone Decanoate", "asFound"=>"Mucoepidermoid carcinoma of the oral cavity", "relevance"=>"HIGH"}, {"id"=>"M12228", "name"=>"Nandrolone", "asFound"=>"Mucoepidermoid carcinoma of the oral cavity", "relevance"=>"HIGH"}, {"id"=>"M241168", "name"=>"Nandrolone phenpropionate", "asFound"=>"Mucoepidermoid carcinoma of the oral cavity", "relevance"=>"HIGH"}, {"id"=>"M4279", "name"=>"Antilymphocyte Serum", "asFound"=>"RASP", "relevance"=>"HIGH"}, {"id"=>"M4059", "name"=>"Androgens", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M3032", "name"=>"Anabolic Androgenic Steroids", "relevance"=>"LOW"}, {"id"=>"M25605", "name"=>"Anabolic Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1982-03"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-05", "completionDateStruct"=>{"date"=>"1988-12", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-11-25", "studyFirstSubmitDate"=>"1999-10-27", "studyFirstSubmitQcDate"=>"1999-10-27", "lastUpdatePostDateStruct"=>{"date"=>"2013-11-26", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-10-28", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"conditions"=>["Anemia, Aplastic", "Hematologic Diseases", "Pancytopenia", "Blood Disease"]}, "referencesModule"=>{"references"=>[{"pmid"=>"3058228", "type"=>"BACKGROUND", "citation"=>"Young N, Griffith P, Brittain E, Elfenbein G, Gardner F, Huang A, Harmon D, Hewlett J, Fay J, Mangan K, et al. A multicenter trial of antithymocyte globulin in aplastic anemia and related diseases. Blood. 1988 Dec;72(6):1861-9."}]}, "descriptionModule"=>{"briefSummary"=>"To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases.", "detailedDescription"=>"BACKGROUND:\n\nAplastic anemia has been shown to respond to ATG. An immunological basis for aplastic anemia has been suggested by previous observations although the precise mechanism of action of ATG has not been defined. This serum, produced by immunization of horses with human thymocytes, may have broad reactivity with many human cells.\n\nDESIGN NARRATIVE:\n\nPatients in Group I with acute severe disease were randomized to receive ATG in either ten day or twenty-eight day courses. Patients in Group II with moderate or chronic disease were randomized to receive either ATG for ten days or high doses of the androgen, nandrolone decanoate. Patients in Group III with a variety of bone marrow diseases were also treated with ATG.\n\nThe study completion date listed in this record was inferred from the last publication listed in the Citations section of this study record."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Men and women with moderate or acute, severe, aplastic anemia."}, "identificationModule"=>{"nctId"=>"NCT00000597", "briefTitle"=>"Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders", "organization"=>{"class"=>"NIH", "fullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "orgStudyIdInfo"=>{"id"=>"403"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"antilymphocyte serum", "type"=>"DRUG"}, {"name"=>"nandrolone", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"Neal Young", "affiliation"=>"Laboratory of Hematology, NHLBI"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}}}}
