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:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT01362595
Eligibility Criteria:
Inclusion Criteria:
* diagnosed with Diamond Blackfan anemia as published in British Journal of Hematology
* transfusion dependent
* age 2 years and older
* adequate renal function
* adequate liver function
* negative B-HCG if patient is a menstruating female and documentation of adequate contraception
* signed informed consent
Exclusion Criteria:
* Known hypersensitivity to branched chain amino acids
* Diagnosis of an inborn error of amino acid metabolism disorder
* Prior hematopoietic stem cell transplantation
* Pregnancy, or plans to become pregnant during duration of trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT01362595
Study Brief:
Protocol Section:
NCT01362595