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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00000597 |
Purpose
To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases.
| Condition | Intervention | Phase |
|
Anemia, Aplastic Hematologic Diseases Pancytopenia Blood Disease |
Drug: antilymphocyte serum Drug: nandrolone |
Phase III |
| MedlinePlus related topics: | Anemia |
| Drug Information available for: | Nandrolone Nandrolone decanoate Nandrolone phenpropionate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Study Start Date: | March 1982 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Men and women with moderate or acute, severe, aplastic anemia.
Contacts and Locations More Information
| Study ID Numbers: | 403 |
| First Received: | October 27, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000597 |
| Health Authority: | United States: Federal Government |
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