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

Chimerix, Inc0 个研究点目标入组 30 人开始时间: 2018年6月21日最近更新: 2019年6月30日

适应症

试验速览

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•For inclusion in this study, subjects must:
•1. Be = 18-years-old (or per local law or regulations on legal age of consent).
•2. Have received an allogeneic HCT within the previous 100 days.
•3. 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).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Diarrhea meeting the US National Institutes of Health (NIH)/National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater (i.e., increase of = 4 stools per day over usual pretransplant stool output) within 7 days prior to Day 1.
•2. Acute graft versus host disease (GVHD) meeting the following criteria:
•: 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 [SI: > 51 µmol/L]) within 7 days prior to Day 1.
•: Any NIH Stage 3 or Stage 4 acute GVHD within 7 days prior to Day 1.
•3. Concurrent human immunodeficiency virus or active hepatitis B or C infection.
•4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5x the upper limit of the normal reference range (ULN), total bilirubin > 3 mg/dL (SI: > 51 µmol/L), or prothrombin time – international normalized ratio (PT-INR) > 2x ULN within 7 days prior to Day 1.

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