Conditions: Viruria
Keywords: CMX001 Kidney transplant HSCT transplant BK Virus Post kidney transplant patients with BK virus viruria > 10^4 Post HSCT transplant patients with BK virus viruria > 10^4
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 29
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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 infection.

Subjects received blinded study medication for a total of 5 doses in 1 of the following regimens:

* 10 mg BCV administered twice weekly (BIW) on Days 0, 3, 7, 10, 14.
* 20 mg BCV administered once weekly (QW) on Days 0, 7, and 14 and placebo administered on Days 3 or 10.
* Placebo administered BIW on Days 0, 3, 7, 10 ,14.
* 40 mg BCV administered QW on Days 0, 7, 14, 21, and 28.
* Placebo administered QW on Days 0, 7, 14, 21, and 28.

Arms:
arm 1: Under Amendments 1 and 2, subjects received 1 of 2 dose regimens of brincidofovir, as follows:

* 20 mg BCV once weekly (QW) on Days 0, 7, and 14; or
* 10 mg BCV twice weekly (BIW) BIW on Days 0, 3, 7, 10, and 14.

Under Amendment 3, subjects received 40 mg BCV QW for a total of 5 doses on Days 0, 7, 14, 21, and 28. arm 2: Under Amendments 1 and 2, subjects received placebo twice weekly (BIW) for a total of 5 doses on Days 0, 3, 7, 10, and 14.

Under Amendment 3, subjects received placebo once weekly (QW) for a total of 5 doses on Days 0, 7, 14, 21, and 28.

Interventions: intervention 1: Placebo intervention 2: Brincidofovir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: