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Trial NCT00000597

Resource URI: http://static.linkedct.org/resource/trials/NCT00000597
linkedct:brief_title Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders
linkedct:condition <http://static.linkedct.org/resource/condition/1708>
linkedct:condition <http://static.linkedct.org/resource/condition/5761>
linkedct:condition <http://static.linkedct.org/resource/condition/935>
linkedct:condition <http://static.linkedct.org/resource/condition/9614>
linkedct:criteria Men and women with moderate or acute, severe, aplastic anemia.
linkedct:description BACKGROUND: Aplastic 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. DESIGN NARRATIVE: Patients 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000597
rdfs:label Trial NCT00000597
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000597
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 403
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/43325>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000597>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/40285>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date March 1982
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct:summary To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases.
rdf:type linkedct:trials
linkedct:verification_date May 2000