Protocol Summary

Protocol No.: OCR14894

Sponsor Protocol No.: CMX001-351

Protocol Title.: Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

Principal Investigator: Slayton, William

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

Phase: N/A

Age Group: Both

Age: 2 Months - N/A

Gender: All

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 Conditions:

  • Pediatric (Childhood) Cancer
  • Supportive Care Trials
  • Participation Institution:

  • UF Gainesville : Beate Oltman Greer
  • Contact:
    Beate Oltman Greer
    Phone: +1 352-294-8744
    Email: bgreer01@ufl.edu

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