Clinical Trial: The Adv Halt Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Placebo-Controlled Multi-Site Phase 2 Study Evaluation the Safety and Efficacy of Preemptive Treatment With CMX001 for the Prevention of Adenovirus Disease F
Brief Summary: The primary objective of this study is to evaluate the safety and efficacy of preemptive treatment with CMX001 versus placebo for the prevention of AdV disease in recipients of HSCT with asymptomatic AdV viremia.
Detailed Summary:
Sponsor: Chimerix
Current Primary Outcome: The primary objective of this study is to evaluate the safety and efficacy of preemptive treatment with CMX001 versus placebo for the prevention of AdV disease in recipients of HSCT with asymptomatic AdV viremia
The outcome measure for the primary endpoint will be "treatment failure". Treatment failure is a composite endpoint consisting of:
- Progression to probable or definitive AdV disease.
- OR increasing AdV viremia during randomized therapy (defined as increase from baseline in AdV viremia by ≥ 1 log10, confirmed on a second measurement, at least one week apart) AND requiring discontinuation from randomized therapy
Original Primary Outcome: Same as current
Current Secondary Outcome: 1. To compare the safety and efficacy of two dosing regimens of CMX001 versus each other and versus placebo in this indication.
2. To compare the incidence of treatment emergent dsDNA viral infections (other than those caused by AdV), in subjects treated with CMX001 QW versus CMX001 BIW versus placebo, initially, for the preemption of adenoviral disease.
3. To characterize the safety and efficacy of CMX001 open-label therapy in patients who meet the primary endpoint of treatment failure during randomized therapy.
Original Secondary Outcome: Same as current
Information By: Chimerix
Dates:
Date Received: November 12, 2010
Date Started: November 2010
Date Completion:
Last Updated: October 31, 2013
Last Verified: October 2013
