A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever
ConditionDengue
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNovartis Pharmaceuticals
About this trial
The purpose of this study is to characterize the effect on dengue viral load, fever clearance time as well as on clinical signs and symptoms with the treatment of EYU688 compared with placebo in patients with dengue fever.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, 18 - 60 years old (inclusive).
Nausea or vomiting.
Presence of rash, aches or pains including headache, muscle or joint pain.
Onset of fever ≤ 48 hours prior to treatment start.
Disqualifiers
Participants with any of abnormalities of clinical laboratory parameters.
Usage of any anticoagulant drugs.
Current significant medical conditions or illness that the investigator considers should exclude the participants, especially those that require continuation of other medications likely to have an interaction with the study drug.
Pregnant or nursing (lactating) women.
Trial design
Design model
Parallel
Treatments tested in this trial
EYU688
DrugEYU688 administered by oral route
Placebo
DrugMatching placebo administered orally as capsules
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: EYU688Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start
Efficacy assessment of EYU688. It will allow to quantify the viremia reduction at 48 hours post treatment start from baseline.
Time frame
From predose to 48 hours post treatment startSecondary outcomes
1
Time from fever onset to start of the first 48 hours period during which the oral temperature remained below 37.5℃
Efficacy assessment of EYU688. It will allow to assess the time needed between fever onset and defervescence.
Time frame
From fever onset to Day 152
Time from fever onset to the first of two consecutive negative viremia by PCR
Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15
Time frame
From fever onset to Day 153
Area under the log-transformed viremia curve (AUC) from the first dose to Day 15
Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day 15
Time frame
From fever onset to Day 154
Changes of viral load over time
Efficacy assessment will allow to assess the viremia kinetic from treatment start to Day15
Time frame
From baseline to Day 15Sponsors and contacts
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Source ClinicalTrials.gov