Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000597
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: