At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 133 enrolled
Drug / intervention
60 mg AIC246 +3 moredrug
Likely dose
60 mg AIC246from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of 12 Weeks' Treatment With a New Antiviral HCMV Drug
In Brief
A Phase 2 clinical trial evaluating 60 mg AIC246, 120 mg AIC246, and 2 other interventions for HCMV Reactivation or HCMV End-Organ Disease. Completed, enrolled 133 participants across 24 sites in 2 countries.
Detailed Summary
The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the chances of the cytomegalovirus becoming active again and causing illness after an HBPC transplant (allogeneic stem cell transplant).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, United States
CollaboratorsQuintiles, Inc.
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2010
Enrollment StartMar 2010
Primary CompletionOct 2011
Study CompletionDec 2011
TodayJul 2026
First PostedFeb 5, 2010
Enrollment StartMar 1, 2010
Primary CompletionOct 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.4 years ago
Interventions
60 mg AIC246drug
Oral administration
120 mg AIC246drug
Oral administration
240 mg AIC246drug
Oral administration
Placeboother
Oral administration