Protocol Summary

Protocol No.: 14894

Sponsor Protocol No.: CMX001-351

Study Title
An Intermediate-size, Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

Principal Investigator(s)
Slayton, William

Objective
This protocol is designed to provide patients with severe adenovirus infection access to Brincidofovir.

Phase: NA

Age Group: Both

Scope: National

Treatment
Brincidofovir
Up to 100mg Brincidofovir twice weekly, not to exceed a total dose of 200mg each week

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 2 months old and older
2. Confirmed serious AdV infection based on clinical symptoms and laboratory testing showing AdV in the blood or other bodily fluids
3. Able to swallow medication, either tablet or liquid

EXCLUSION CRITERIA:
1. Previous dosing with Brincidofovir
2. If female, not pregnant or trying to become pregnant

Applicable Disease Sites
Pediatric (Childhood) Cancer
Supportive Care Trials

Participating Institutions
UF Gainesville

Contact
Ashley Bayne, RN
Phone: 352-294-8745

Email: abayne@ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT02596997