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

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 15, 2018

Primary Completion Date

May 10, 2019

Study Completion Date

May 10, 2019

Conditions
Adenovirus
Interventions
DRUG

Brincidofovir

Subjects will receive BCV administered as a continuous IV infusion over 2 hours twice weekly (on Days 1, 4, 8, and 11) for a period of 2 weeks (total of 4 doses).

DRUG

Standard of Care

"Subjects randomized to the SoC in each cohort will be managed per local institutional guidelines and investigator judgement. SoC treatment options may include, but are not limited to, taking a watch and-wait approach, with or without decreased immunosuppression (i.e., no active treatment), or treatment with IV CDV, ganciclovir, or ribavirin."

Trial Locations (8)

8035

Hospital Universitari Vall d'Hebron, Barcelona

20132

University Vita-Salute San Raffaele. San Faffaele Scientific Institute, Milan

37007

Hospital Clinico Universitario de Salamanca, Salamanca

46016

Hospital Universitari I Politecnic la Fe, Valencia

60637

University of Chigago, Chicago

77030

MD Anderson Cancer Center, Houston

90095

UCLA Medical Center, Los Angeles

02115

Brigham and Womens Hospital, Boston

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY