A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
Start Date
8/16/2021
Completion Date
9/30/2026
Summary
The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly (BIW) or 0.4 mg/kg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV
Detailed Description
This is a Phase IIa, open-label, multiple ascending dose confirmation, multicenter study to evaluate the safety and tolerability of intravenous Brincidofovir (BCV, SyB V-1901) 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg dosed BIW or 0.4 mg/kg dosed QW (Cohorts 1 to 4) in adult and pediatric subjects with AdV viremia, and IV BCV in subjects with CMV.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
BCV
Conditions
Locations
Research Site
Los Angeles, California 90027
United States
Research Site
Los Angeles, California 90095
United States
Research Site
San Francisco, California 94158
United States
Research Site
Chicago, Illinois 60637
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Research Site
Durham, North Carolina 27710
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Research Site
Philadelphia, Pennsylvania 19104
United States
St. Jude Children's Research Hospital
Memphis, Tennessee 38105
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Research Site
Seattle, Washington 98109
United States