Back to resultsMulti-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders
Primary Purpose
Anemia, Aplastic, Hematologic Diseases, Pancytopenia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
antilymphocyte serum
nandrolone
Sponsored by
About this trial
This is an interventional treatment trial for Anemia, Aplastic
Eligibility Criteria
Men and women with moderate or acute, severe, aplastic anemia.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000597
First Posted
October 27, 1999
Last Updated
November 25, 2013
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000597
Brief Title
Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
May 2000
Overall Recruitment Status
Completed
Study Start Date
March 1982 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1988 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases.
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.
The study completion date listed in this record was inferred from the last publication listed in the Citations section of this study record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Aplastic, Hematologic Diseases, Pancytopenia, Blood Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
antilymphocyte serum
Intervention Type
Drug
Intervention Name(s)
nandrolone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men and women with moderate or acute, severe, aplastic anemia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Young
Organizational Affiliation
Laboratory of Hematology, NHLBI
12. IPD Sharing Statement
Citations:
PubMed Identifier
3058228
Citation
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.
Results Reference
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Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders
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