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.
This is a randomized, participant- and investigator- blinded, placebo-controlled study to investigate the efficacy and safety of EYU688 administered orally in patients with dengue fever. Due to the different PK sampling schedules applied, the study consists of two cohorts run in parallel (intensive PK \[cohort 1\] and sparse PK sampling \[cohort 2\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
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 start
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 15
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 15
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 15
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 15
Incidence and severity of Adverse Events (AEs)
Incidence and severity of AEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Time frame: From inclusion to Day 15
Incidence and severity of Serious Adverse Events (SAEs)
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Novartis Investigative Site
Manaus, Amazonas, Brazil
RECRUITINGNovartis Investigative Site
Brasília, Federal District, Brazil
RECRUITINGNovartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil
RECRUITINGNovartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGNovartis Investigative Site
São Caetano do Sul, São Paulo, Brazil
RECRUITINGNovartis Investigative Site
São José do Rio Preto, São Paulo, Brazil
RECRUITINGNovartis Investigative Site
Sorocaba, São Paulo, Brazil
RECRUITINGNovartis Investigative Site
Barranquilla, Atlántico, Colombia
RECRUITINGNovartis Investigative Site
Bucaramanga, Santander Department, Colombia
RECRUITINGNovartis Investigative Site
Cali, Valle del Cauca Department, Colombia
RECRUITING...and 17 more locations
Incidence and severity of SAEs by treatment group
Time frame: From inclusion to Day 35
Change of white blood cell count over time from baseline
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
Change of platelet count over time
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
Change of hematocrit level and percentage increase from baseline over time
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
Change of AST, ALT levels over time
Assessment of safety and tolerability of EYU688
Time frame: From baseline to Day 15
No warning signs by day 7 of fever onset
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Diagnosis of severe dengue fever
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Diagnosis of dengue hemorrhagic fever (DHF)
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Plasma leakage
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Requiring fluid infusion
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From inclusion to Day 15
Time from fever onset to clinical recovery
Assessment of the dengue fever clinical evolution under EYU688
Time frame: From fever onset to Day 15
PK parameter (Cmax)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6
PK parameter (Tmax)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6
PK parameter (partial AUCs)
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6
PK concentrations following multiple doses
Pharmacokinetic assessment of EYU688 in dengue fever patients
Time frame: From Day 1 to Day 6