CMX001 in Post-transplant Patients With BK Virus Viruria
Completed
Chimerix
Phase 1/Phase 2
2009-11-01
This was a randomized, double-blind, multiple-dose placebo-controlled study of oral
brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients
with BK virus viruria.
Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients
Completed
Chimerix
Phase 2
2009-10-01
This was a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study
of brincidofovir (BCV) administered orally once or twice weekly for up to 11 weeks. Dosing
was initiated immediately following engraftment (between Days 14-30 post-transplant) to
prevent/control cytomegalovirus (CMV) infection or prevent disease in R+ hematopoietic stem
cell transplant (HCT) recipients.
Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses
Completed
Chimerix
Phase 3
2010-12-01
This was a multicenter, open-label study of oral brincidofovir (BCV) treatment of serious
disease or conditions caused by double-stranded DNA (dsDNA) virus(es). Subjects received
either a weight-based or a fixed dose of oral BCV once weekly (QW) or twice weekly (BIW) for
up to 3 months until clinical disease was resolved or stabilized and/or viral DNA by
polymerase chain reaction testing was negative for 4 consecutive weeks, whichever was longer.
Under the first protocol amendment, adults and adolescents (≥13 years) received 200 mg or 300
mg BCV BIW (not to exceed 4 mg/kg total weekly dose) depending on the difficulty of treating
their disease (i.e., Group 1 or Group 2, respectively), and pediatric subjects (≤12 years)
received 4 mg/kg BCV BIW. Under the second protocol amendment, adults and adolescents (≥13
years), regardless of viral infection/disease, had a maximum weekly dose of 200 mg, i.e., 200
mg QW or 100 mg BIW; not to exceed 4mg/kg total weekly dose. Pediatric subjects (≤12 years),
regardless of viral infection/disease, had a maximum weekly dose of 4 mg/kg, i.e., 4 mg/kg QW
or 2 mg/kg BIW; not to exceed 200 mg.
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