CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Valomaciclovir +1 moredrug
Likely dose
Not stated in 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.

Search/NCT00575185
NCT00575185Phase 2Completed
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Randomized, Placebo-Controlled, Double-Blind Study to Assess Clinical and Antiviral Activity of Valomaciclovir (EPB 348) in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection (Mono 6)

University of Minnesota·interventional·Posted Dec 18, 2007·Updated Mar 22, 2017

In Brief

A Phase 2 clinical trial evaluating Valomaciclovir and placebo for Infectious Mononucleosis. Completed, enrolled 23 participants across 1 site.

Detailed Summary

This will be a randomized, placebo-controlled, double-blind single-center proof of concept study to evaluate the anti-EBV activity of 4 grams of valomaciclovir (2 grams BID) for 21 days in subjects with infectious mononucleosis documented to be caused by primary EBV infection. Otherwise healthy subjects (≥15 years old) referred to us with a clinical diagnosis of primary infectious mononucleosis will be screened and those with laboratory-confirmed primary EBV infection will be enrolled.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfectious Mononucleosis
CountriesUnited States
CollaboratorsEpiphany Biosciences

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 18, 2007
Enrollment StartNov 1, 2007
Primary CompletionJul 1, 2009
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.5 years ago

Interventions

Valomaciclovirdrug

4 grams orally of valomaciclovir (2 grams BID) for 21 days.

placebodrug

Placebo tablets orally twice daily for 21 days.