Mycophenolate Mofetil and Cyclosporine to Treat Relapsing Aplastic Anemia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00005935
• Date of registration: 06/07/2000
• Prospective Registration: No
• 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

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: Mycophenolate mofetil

Drug: Cyclosporine

Secondary ID(s)

000157

00-H-0157

Source(s) of Monetary Support

Please refer to primary and secondary sponsors