Therapeutic approaches against dengue virus: current status of vaccines, antivirals, and monoclonal antibodies.
Hawa Sophia Bouzidi, Xavier De Lamballerie, Franck Touret
https://pubmed.ncbi.nlm.nih.gov/42253092/Actively Recruiting
Led by Novartis Pharmaceuticals · Updated on 2026-07-15
108
Participants Needed
24
Research Sites
1 weeks
Total Duration
Researchers are evaluating the effects of EYU688, an oral drug, compared with a placebo in patients with dengue fever. The study aims to understand how EYU688 influences dengue viral load, fever clearance time, and clinical symptoms. This randomized, participant- and investigator-blinded, placebo-controlled trial includes two patient groups based on different pharmacokinetic sampling schedules. Participants will receive either EYU688 or a matching placebo orally. The study runs two cohorts in parallel one with intensive pharmacokinetic sampling and another with sparse sampling. Treatment and assessments occur from the start of dosing through Day 15, with additional safety monitoring up to Day 35. The study measures drug concentration levels and viral load changes over time. Throughout the study, participants will undergo evaluations including viral load tests, fever monitoring, blood tests for blood cells and liver enzymes, and assessments for dengue severity. Safety and adverse events are recorded up to Day 35. The primary outcome is viral load reduction at 48 hours after treatment begins. Participation lasts until study completion, expected by July 2027.
CONDITIONS
A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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Novartis Pharmaceuticals
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 15 days
Participants receive either the study drug EYU688 or a matching placebo orally as capsules.
Regular visits for assessments and monitoring
Duration - Up to 35 days
Participants are monitored for adverse events and safety up to Day 35.
Scheduled follow-up visits for safety assessments
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Hawa Sophia Bouzidi, Xavier De Lamballerie, Franck Touret
https://pubmed.ncbi.nlm.nih.gov/42253092/Novartis Pharmaceuticals
Lead Sponsor