A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Den
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.
| Condition(s) | Dengue |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 | 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 f |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Lead sponsor | Novartis Pharmaceuticals |
| Locations | Manaus, Amazonas, Brazil; Brasília, Federal District, Brazil; Rio de Janeiro, Rio de Janeiro, Brazil; Sorocaba, São Paulo, Brazil; Sao Jose Rio Preto, Brazil; Barranquilla, Atlántico, Colombia (+17 more sites) |
| Start date | 2024-02-20 |
| NCT ID | NCT06006559 |
| Official listing | https://clinicaltrials.gov/study/NCT06006559 |