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

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 3

Conditions

Blood Disease
Anemia, Aplastic
Pancytopenia
Hematologic Diseases

Treatments

Drug: antilymphocyte serum
Drug: nandrolone

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000597
403

Details and patient eligibility

About

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

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

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Men and women with moderate or acute, severe, aplastic anemia.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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