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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT05179057
Eligibility Criteria:
Inclusion Criteria:
* Undergone allogeneic cell transplantation ≥21 days prior to dosing
* Meet one of the below criteria:
1. AdV viremia DNA ≥10,000 copies/mL, OR
2. AdV viremia DNA results of ≥1,000 copies/mL, AND
1. has absolute lymphocyte count \<180/mm3, OR
2. has received T cell depletion OR
3. had a cord blood transplant.
Exclusion Criteria:
* Grade 3 or higher acute GVHD
* Ongoing therapy with high-dose systemic corticosteroids
* Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
* Pregnant or lactating female unwilling to discontinue nursing prior to randomization
* History of severe prior reactions to blood product transfusions
NOTE: Other protocol-defined inclusion/exclusion criterion may apply.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05179057
Study Brief:
Protocol Section:
NCT05179057