Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00061360
Eligibility Criteria:
* INCLUSION CRITERIA:
Severe aplastic anemia confirmed at NIH by:
1. . Bone marrow cellularity less than 30% (excluding lymphocytes)
2. . At least two of the following: Absolute neutrophil count less than 500/ uL; Platelet count less than 20,000/ uL; Absolute reticulocyte count less than 60,000/ uL
Age greater than or equal to 2 years old
Weight greater than 12 kg
EXCLUSION CRITERIA:
Serum creatinine greater than 2.5 mg/dL
Underlying carcinoma (except local cervical, basal cell, squamous cell)
Prior immunosuppressive therapy with ATG, ALG, or high dose cyclophospamide.
Current pregnancy or lactation or unwillingness to take oral contraceptives or use an effective method of birth control.
Diagnosis of Fanconi anemia or other congenital bone marrow failure syndromes
Evidence of a clonal disorder on cytogenetics. Patients with super severe neutropenia (ANC less than 200/uL) will not be excluded if results of cytogenetics are not available or pending.
Underlying immunodeficiency state including seropositivity for HIV
Inability to understand the investigational nature of the study or give informed consent
Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient s ability to tolerate protocol therapy, or that death within 7-10 days is likely.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
110 Years
Study:
NCT00061360
Study Brief:
Protocol Section:
NCT00061360