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Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000597
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 26, 2013
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases.

Condition or disease Intervention/treatment Phase
Anemia, Aplastic Hematologic Diseases Pancytopenia Blood Disease Drug: antilymphocyte serum Drug: nandrolone Phase 3

Detailed Description:


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.


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.

The study completion date listed in this record was inferred from the last publication listed in the Citations section of this study record.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : March 1982
Actual Study Completion Date : December 1988

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Men and women with moderate or acute, severe, aplastic anemia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000597

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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OverallOfficial: Neal Young Laboratory of Hematology, NHLBI
Layout table for additonal information Identifier: NCT00000597    
Other Study ID Numbers: 403
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: May 2000
Additional relevant MeSH terms:
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Hematologic Diseases
Anemia, Aplastic
Bone Marrow Diseases
Nandrolone Decanoate
Nandrolone phenpropionate
Antilymphocyte Serum
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anabolic Agents
Bone Density Conservation Agents
Immunologic Factors
Immunosuppressive Agents