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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT03532035
Eligibility Criteria:
Inclusion Criteria:
* Be ≥ 18-years-old (or per local law or regulations on legal age of consent).
* Have received an allogeneic hematopoietic cell transplant (HCT) within the previous 100 days.
* Have plasma AdV DNA viremia ≥ 1,000 copies/mL (via quantitative polymerase chain reaction assay; local results must be confirmed by the designated central virology laboratory).
Exclusion Criteria:
* Diarrhea meeting the US National Institutes of Health (NIH)/National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater
* Acute graft versus host disease (GVHD)
1. NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea \> 1,000 mL/day, or severe abdominal pain with or without ileus) or liver (i.e., bilirubin \> 3 mg/dL : \> 51 μmol/L) within 7 days prior to Day 1
2. Any NIH Stage 3 or Stage 4 acute GVHD within 7 days prior to Day 1
* Concurrent human immunodeficiency virus or active hepatitis B or C infection
* An estimated creatinine clearance of \< 30 mL/min, and/or use of renal replacement therapy within 7 days prior to Day 1.
* Poor clinical prognosis, including active malignancy, irreversible organ failure, use of vasopressors, requirement for mechanical ventilation, resting oxygen saturation \< 88%, or Pulmonary Arterial oxygen (PaO2) ≤ 55 mm Hg without supplemental oxygen at any time within 7 days prior to Day 1.
* Receiving or anticipated to start systemic cyclosporine immunosuppressant treatment during study participation.
* Received treatment with CDV within 14 days prior to Day 1.
* Previous receipt of cell-based anti-AdV therapy within 6 weeks prior to Day 1 or prior receipt of an anti-AdV vaccine at any time.
* Consumed food products containing sesame seeds, sesame oil, or dietary supplements containing sesamin within 3 days prior to Day 1.
* Received any investigational drug within 28 days prior to Day 1 or currently participating in another interventional study.
* Pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03532035
Study Brief:
Protocol Section:
NCT03532035