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

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

Completed

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Key information

Conditions

Anemia, Aplastic Anemia Blood Disease Bone Marrow Diseases Bone Marrow Failure Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Pancytopenia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antilymphocyte serum

Drug

nandrolone

Drug

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start: 1982
Study completion: 1988
First posted: Oct 28, 1999
Registry last updated: Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed