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A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever

RecruitingPhase 2Ages 18 Years - 60 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 3 X 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 screening. * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 4 days after stopping of investigational drug. * History or long-QT syndrome, or clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening: * QTcF \> 450 msec (males) * QTcF \> 460 msec (females) Other protocol-defined inclusion/exclusion criteria may apply.
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What it tests

  • EYU688
  • Placebo
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Where

27 sites
Novartis Investigative Site
Manaus, Brazil
Novartis Investigative Site
Brasília, Brazil
Novartis Investigative Site
Rio de Janeiro, Brazil
Novartis Investigative Site
Porto Alegre, Brazil
Novartis Investigative Site
São Caetano do Sul, Brazil
Novartis Investigative Site
São José do Rio Preto, Brazil
Novartis Investigative Site
Sorocaba, Brazil
Novartis Investigative Site
Barranquilla, Colombia

…and 19 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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