Status:
COMPLETED
Neuropsychological Effects of Immunosuppressive Treatment in Subjects With Aplastic Anemia
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Aplastic Anemia
Eligibility:
All Genders
15+ years
Brief Summary
This study will use neuropsychological tests to look at nervous system side effects of Cyclosporine (CsA) in patients with aplastic anemia. CsA is used as part of an immunosuppressive regimen in treat...
Detailed Description
Cyclosporine (CsA) is widely used in the treatment of aplastic anemia as well as to provide immunosuppression after transplantation. CsA has a spectrum of neurologic and more subtle, poorly investigat...
Eligibility Criteria
Inclusion
- INCULSION CRITERIA:
- Diagnosed with aplastic anemia.
- Co-enrolled on a Clinical Center CsA treatment protocol that prescribes CsA (included but not limited to initial treatment cohort in both rabbit and horse ATG arm for the aplastic anemia patients).
- Age greater than or equal to 15 years old.
- EXCLUSION CRITERIA:
- Prior use of cyclosporine within 6 months to next line of treatment.
- History of learning disability (i.e. dyslexia).
- Unable to read and speak English (the neuropsychological testing tools are validated for use in English speaking subjects only).
- Life expectancy less than six months or when clinical status prevents full performance with testing.
- Either adult patients or guardians for the minor patient, unable to comprehend the investigational nature of the study and provide informed consent.
- Inability or unwillingness to come to Clinical Center for the 6-month and 12-month follow-up appointments.
Exclusion
Key Trial Info
Start Date :
September 23 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 28 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00767650
Start Date
September 23 2008
End Date
June 28 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892