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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: 12 December 2020
Main ID:  NCT00001964
Date of registration: 18/01/2000
Prospective Registration: No
Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Public title: Combination Therapy of Severe Aplastic Anemia
Scientific title: Treatment of Severe Aplastic Anemia With Combined Immunosuppression: Antithymocyte Globulin (ATG) and Cyclosporine A (CSA), and Mycophenolate Mofetil (MMF)
Date of first enrolment: December 2, 1999
Target sample size: 104
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00001964
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Neal S Young, M.D.
Address: 
Telephone:
Email:
Affiliation:  National Heart, Lung, and Blood Institute (NHLBI)
Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

Only patients with SAA will be admitted, defined as:

Bone marrow cellularity less than 30%.

At least two of the following blood count findings: absolute granulocyte count less than
500/mm(3); platelet count less than 20,000/mm(3); reticulocyte count less than
60,000/mm(3).

Age greater than or equal to 1 years.

Weight greater than 12 kg.

EXCLUSION CRITERIA:

Serum creatinine greater than 2 mg/dl or estimated creatinine clearance less than 40
ml/min.

Underlying carcinoma, recent history of radiation or chemotherapy.

Current pregnancy or unwillingness to be treated with oral contraceptives.

Inability to comprehend the investigational nature of the study.

Moribund status or concurrent hepatic, renal, cardiac, neurologic, or metabolic disease of
such severity that death within 7 to 10 days is likely.

Evidence of other etiology than AA for bone marrow failure, including positive clastogenic
stress cytogenetic assay for Fanconi anemia and marrow chromosome abnormalities typical of
myelodysplasia.



Age minimum: 1 Year
Age maximum: 99 Years
Gender: All
Health Condition(s) or Problem(s) studied
Severe Aplastic Anemia
Intervention(s)
Drug: ATG
Drug: Cyclosporine A
Drug: MMF
Primary Outcome(s)
reduction in 24-month relapse [Time Frame: 24 months]
Secondary Outcome(s)
Secondary ID(s)
00-H-0032
000032
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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