NCT00000597

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 1982

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1982

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1988

Completed
10.9 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 26, 2013

Status Verified

May 1, 2000

First QC Date

October 27, 1999

Last Update Submit

November 25, 2013

Conditions

Anemia, AplasticHematologic DiseasesPancytopeniaBlood Disease

Interventions

antilymphocyte serumDRUG
nandroloneDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women with moderate or acute, severe, aplastic anemia.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 3058228BACKGROUND

MeSH Terms

Conditions

Anemia, AplasticHematologic DiseasesPancytopenia

Interventions

Antilymphocyte SerumNandrolone

Condition Hierarchy (Ancestors)

AnemiaHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow DiseasesCytopenia

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Neal Young

    Laboratory of Hematology, NHLBI

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

March 1, 1982

Study Completion

December 1, 1988

Last Updated

November 26, 2013

Record last verified: 2000-05