drugset / Trial / NCT01241344
Phase 2 Study to Evaluate Brincidofovir for the Prevention of Adenovirus Disease
RandomizedParallel-groupDouble-blindTreatment
Summary
This study was designed to assess the safety and efficacy of preemptive treatment with oral brincidofovir (BCV), as compared to placebo, for the prevention of adenovirus (AdV) disease in recipients of hematopoietic stem cell transplantation (HCT) with asymptomatic AdV viremia.
Timeline
- Start
- 2010-11
- Primary completion
- 2013-06
- Completion
- 2013-06
Publications
- Results Grimley MS, Chemaly RF, Englund JA, Kurtzberg J, Chittick G, Brundage TM, Bae A, Morrison ME, Prasad VK. Brincidofovir for Asymptomatic Adenovirus Viremia in Pediatric and Adult Allogeneic Hematopoietic Cell Transplant Recipients: A Randomized Placebo-Controlled Phase II Trial. Biol Blood Marrow Transplant. 2017 Mar;23(3):512-521. doi: 10.1016/j.bbmt.2016.12.621. Epub 2017 Jan 5.
- Tippin TK, Morrison ME, Brundage TM, Mommeja-Marin H. Brincidofovir Is Not a Substrate for the Human Organic Anion Transporter 1: A Mechanistic Explanation for the Lack of Nephrotoxicity Observed in Clinical Studies. Ther Drug Monit. 2016 Dec;38(6):777-786. doi: 10.1097/FTD.0000000000000353.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Brincidofovir | Other / unclassified | 2 mg/kg | Oral |
| Comparator | Brincidofovir | Other / unclassified | 4 mg/kg | Oral |
| Comparator | Brincidofovir | Other / unclassified | 100 mg | Oral |
| Comparator | Brincidofovir | Other / unclassified | 200 mg | Oral |