Nctid:
NCT00002073
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000740", "term"=>"Anemia"}, {"id"=>"D000095542", "term"=>"Cytopenia"}], "ancestors"=>[{"id"=>"D006402", "term"=>"Hematologic Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M4070", "name"=>"Anemia", "asFound"=>"Anemia", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M3170", "name"=>"Cytopenia", "asFound"=>"Cytopenia", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000068817", "term"=>"Epoetin Alfa"}], "ancestors"=>[{"id"=>"D006397", "term"=>"Hematinics"}], "browseLeaves"=>[{"id"=>"M314", "name"=>"Epoetin Alfa", "asFound"=>"Biomarker analysis", "relevance"=>"HIGH"}, {"id"=>"M17920", "name"=>"Zidovudine", "relevance"=>"LOW"}, {"id"=>"M9485", "name"=>"Hematinics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1989-12", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Recombinant Proteins", "Injections, Subcutaneous", "Erythropoietin", "Acquired Immunodeficiency Syndrome", "Anemia", "Zidovudine"], "conditions"=>["HIV Infections", "Cytopenias"]}, "descriptionModule"=>{"briefSummary"=>"To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Maintenance dose of zidovudine (AZT) of at least 400 mg daily.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* History of any primary hematologic disease.\n* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.\n* AIDS-related dementia.\n* Uncontrolled hypertension (diastolic blood pressure \\> 100 mmHg).\n* Presence of concomitant iron deficiency.\n* Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.\n* Acute opportunistic infection.\n* History of seizures.\n\nPatients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.\n\n* Must not have previously participated in any other r-HuEPO clinical studies.\n\nPrior Medication:\n\nExcluded within 30 days of study entry:\n\n* Experimental drug or experimental device.\n* Cytotoxic chemotherapy.\n* Excluded within 2 months of study entry:\n* Androgen therapy.\n\nClinical diagnosis of AIDS and related anemia.\n\n* Clinical diagnosis of AIDS.\n* Clinically stable for 1 month preceding study entry.\n* Maintenance dose of zidovudine (AZT) of at least 400 mg daily.\n\nSubstance abuse."}, "identificationModule"=>{"nctId"=>"NCT00002073", "briefTitle"=>"A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy", "orgStudyIdInfo"=>{"id"=>"004E"}, "secondaryIdInfos"=>[{"id"=>"I88-009"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Epoetin alfa", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"088690602", "city"=>"Raritan", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Ortho Pharmaceutical Corp", "geoPoint"=>{"lat"=>40.56955, "lon"=>-74.63294}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ortho Pharmaceuticals", "class"=>"INDUSTRY"}}}}
