Assessing the effects of EYU688 on dengue fever
A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever
This study is testing a new treatment called EYU688 to see if it can help people with dengue fever feel better and recover faster compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 23 sites (Manaus, Amazonas and 22 other locations) |
| Trial ID | NCT06006559 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of EYU688 in treating patients with dengue fever compared to a placebo. It is a randomized, participant- and investigator-blinded, placebo-controlled trial that aims to measure the impact of EYU688 on dengue viral load, fever clearance time, and clinical symptoms. The study includes two cohorts with different pharmacokinetic sampling schedules to gather comprehensive data on the drug's effects.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 60 who have a confirmed dengue infection and have experienced fever within the last 48 hours.
Not a fit: Patients with severe dengue symptoms or significant medical conditions that require other medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery times and clinical outcomes for patients suffering from dengue fever.
How similar studies have performed: While there have been studies on dengue treatments, the specific approach with EYU688 is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Manaus, Amazonas and 22 other locations
- Novartis Investigative Site — Manaus, Amazonas, Brazil (Recruiting)
- Novartis Investigative Site — Brasília, Federal District, Brazil (Recruiting)
- Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil (Recruiting)
- Novartis Investigative Site — Sorocaba, São Paulo, Brazil (Recruiting)
- Novartis Investigative Site — Sao Jose Rio Preto, Brazil (Recruiting)
- Novartis Investigative Site — Barranquilla, Atlántico, Colombia (Recruiting)
- Novartis Investigative Site — Bucaramanga, Santander Department, Colombia (Recruiting)
- Novartis Investigative Site — Cali, Valle del Cauca Department, Colombia (Recruiting)
- Novartis Investigative Site — Belagavi, Karnataka, India (Recruiting)
- Novartis Investigative Site — Mumbai, Maharashtra, India (Withdrawn)
- Novartis Investigative Site — Pune, Maharashtra, India (Recruiting)
- Novartis Investigative Site — Jaipur, Rajasthan, India (Recruiting)
- Novartis Investigative Site — Chennai, Tamil Nadu, India (Recruiting)
- Novartis Investigative Site — Kuantan, Pahang, Malaysia (Recruiting)
- Novartis Investigative Site — Ipoh, Perak, Malaysia (Recruiting)
- Novartis Investigative Site — Seberang Jaya, Pulau Pinang, Malaysia (Recruiting)
- Novartis Investigative Site — Miri, Sarawak, Malaysia (Recruiting)
- Novartis Investigative Site — Kuala Selangor, Malaysia (Recruiting)
- Novartis Investigative Site — Singapore, Singapore (Recruiting)
- Novartis Investigative Site — Singapore, Singapore (Recruiting)
- Novartis Investigative Site — Haiphong, Vietnam (Recruiting)
- Novartis Investigative Site — Hanoi, Vietnam (Recruiting)
- Novartis Investigative Site — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.