Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:2/13/2019
Start Date:December 15, 2018
End Date:December 20, 2019
Contact:Garrett Nichols, MD, MS
Email:gnichols@chimerix.com
Phone:919-287-6006

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A Randomized, Controlled, Open-Label, Multiple Ascending Dose Study of Intravenous Brincidofovir in Adult Allogeneic Hematopoietic Cell Transplant Recipients With Adenovirus Viremia

This is a randomized, controlled, open-label, multicenter study to evaluate the safety,
tolerability, pharmacokinetic (PK), and adenovirus (AdV) antiviral activity of multiple
ascending doses of IV brincidofovir (BCV). Approximately 30 eligible subjects will be
sequentially enrolled into 1 of 3 planned cohorts. Within each cohort, subjects will be
randomized in a 4:1 ratio to receive IV BCV dosed twice weekly (BIW) (on Days 1, 4, 8, and
11) or to receive investigator-assigned standard of care (SoC).


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.
We found this trial at
5
sites
Houston, Texas 77030
Principal Investigator: Roy Chemaly, MD
Phone: 713-563-6943
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Fransicso Marty, MD
Phone: 617-525-6778
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Chicago, Illinois 60637
Principal Investigator: Kate Mullane, MD
Phone: 773-702-1665
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Drew Winston, MD
Phone: 310-794-8600
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Milan, 20132
Principal Investigator: Fabio Ciceri
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