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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00005935
Date of registration: 06/07/2000
Prospective Registration: Yes
Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Public title: Mycophenolate Mofetil and Cyclosporine to Treat Relapsing Aplastic Anemia
Scientific title: A Randomized Trial for the Treatment of Relapsing Aplastic Anemia With Mycophenolate Mofetil (MMF) and Cyclosporine (CSA)
Date of first enrolment: June 2000
Target sample size: 130
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00005935
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

Subjects with a history of severe aplastic anemia successfully treated by
immunosuppression will be included.

Subjects with relapse, as defined above by either return of blood counts to satisfy
criteria for severity or consistently declining blood counts will be included.

Subjects age 4 and above will be included.

Subjects with the presence of a medical or surgical condition making survival for at least
3 months unlikely will be excluded.

Subjects with inability to confer informed consent or assent, in the case of a child,
either written or verbal, will be excluded.



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Aplastic Anemia
Intervention(s)
Drug: Cyclosporine
Drug: Mycophenolate mofetil
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
00-H-0157
000157
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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