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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03645460
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of classical ADA-SCID based on:
* A proven defective adenosine deaminase (ADA) gene as defined by direct sequencing of patient DNA.
* T-cell immune deficiency defined as one or more of the following: CD3+ autologous T cells \< 300/ul, or less than 50% of normal value for in vitro mitogen stimulation, or absent proliferation in vitro to antigens.
* With severe infections, including but not limited to: pneumonitis; protracted diarrhea requiring total parenteral nutrition; infection with herpes viruses or adenovirus or fungus; disseminated BCG infection.
* No cytogenetic abnormalities (medullary karyotype) and no detection of main rearrangements associated with acute leukemia of children.
* No prior allogeneic stem cell transplantation.
* Life expectancy ≥ 2 months.
* Negative for HIV infection.
* Written, informed consent obtained prior to any study-specific procedures.
Exclusion Criteria:
* None
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Study:
NCT03645460
Study Brief:
Protocol Section:
NCT03645460