Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jazz Pharmaceuticals
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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.
Clareo Health | Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia
