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

This study has been completed.

First Received on October 27, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Anemia Aplastic Anemia

Drug Information available for: Nandrolone decanoate Antilymphocyte Serum

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:

March 1982

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000597

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:

Neal Young

Laboratory of Hematology, NHLBI

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00000597 History of Changes
Other Study ID Numbers:	403
Study First Received:	October 27, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Anemia
Anemia, Aplastic
Hematologic Diseases
Pancytopenia
Bone Marrow Diseases
Antilymphocyte Serum
Nandrolone
Nandrolone decanoate
Nandrolone phenpropionate

Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anabolic Agents

ClinicalTrials.gov processed this record on May 24, 2012