Trial intelligence / Profile preview

Brincidofovir in Post-Transplant Subjects With BK Virus Viruria

NCT00793598Phase 2

Key facts

Status
Completed
Start
Nov 2009
Primary completion
Oct 2010
Countries
1
Modality
Metabolically Activated Prodrugs
Conditions
BK virus infection
01

Overview

Phase 2, randomised, double-blind trial in BK virus infection comparing Brincidofovir with Placebo (2 arms). Primary endpoint: Number of Adverse Events at 35 days. Started Nov 2009; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Brincidofovir

    Experimental arm receiving various doses of BCV

  • Placebo

    Placebo comparator arm

03

Endpoints

Primary

  • Number of Adverse Events

Secondary

  • Percentage of Patients Who Achieved BK Viruria Resolution

  • Number of Patients Who Achieved a Clinically Significant Decrease in BK Viruria

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