A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever (NCT06006559) | Clinical Trial Compass
RecruitingPhase 2
A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever
Brazil108 participantsStarted 2024-02-20
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, 18 - 60 years old (inclusive).
* History or presence of fever (≥ 38°C). At least one of the following criteria indicating dengue infection:
* Nausea or vomiting.
* Presence of rash, aches or pains including headache, muscle or joint pain.
* Onset of fever ≤ 48 hours prior to treatment start.
* Positive test on dengue fever.
Exclusion Criteria:
* 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.
* Clinical signs and symptoms for severe dengue according to Dengue Guideline (WHO 2009) at screening.
* Participants with any of the following abnormalities of clinical laboratory parameters at screening:
* Hemoglobin \<12.0 g/dL in males; \<11.0 g/dL in females
* Hematocrit \>52 % in males; \>46 % in females
* Absolute neutrophil count \<1500/μL
* Platelet count \<80,000/mm3
* Creatinine \>165 μmol/L in males; \>130 μmol/L in females
* Serum creatine kinase \> 600 U/L
* ALT, AST levels more than 1.5X upper limit of normal (ULN)
* Total bilirubin \>24 μmol/L
* Usage of PPIs (proton pump inhibitor) which could affect absorption of EYU688 due to stomach pH value increase up to 48 hours prior to screenin…
What they're measuring
1
Viremia reduction (viral load reduction (VLR) on log scale) at 48 hours post treatment start
Timeframe: From predose to 48 hours post treatment start