To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases...
Date First Received: October 27, 1999
Last Updated: June 23, 2005
Verified by: National Heart, Lung, and Blood Institute (NHLBI), May 2000
Clinical Trial Phase: Phase 3 | Start Date: March 1982
Overall Status: Completed
Brief Summary
Condition Keyword(s):
Intervention(s):
To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases.
Study Type: Interventional
Study Design: Treatment, Randomized
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: antilymphocyte serum
- Drug: nandrolone
Criteria for Participation in this Clinical Trial
- Men and women with moderate or acute, severe, aplastic anemia.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Overall Clinical Trial Officials and Contacts
Neal Young Laboratory of Hematology, NHLBI
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on January 06, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000597
Study ID Number: 403
ClinicalTrials.gov Identifier: NCT00000597
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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