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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1982-03-31

Study Completion Date

1988-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Anemia, Aplastic Hematologic Diseases Pancytopenia Blood Disease

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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antilymphocyte serum

Intervention Type DRUG

nandrolone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Neal Young

Role:

Laboratory of Hematology, NHLBI

References

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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.

Reference Type BACKGROUND

PMID: 3058228 (View on PubMed)

Other Identifiers

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403

Identifier Type: -

Identifier Source: org_study_id