NCT00793598

CMX001 in Post-transplant Patients With BK Virus Viruria

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of the Safety, Tolerability and Population Pharmacokinetics of CMX001 in Post-Transplant Subjects With BK Virus Viruria

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Viruria

Interventions

Type	Name	Description
DRUG	Placebo
DRUG	Brincidofovir

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2008-11-19
• Last updated: 2021-08-16
• Results posted: 2021-07-16

Locations

15 sites across 1 country: United States