A study to assess the efficacy and safety of EYU688 in patients with dengue fever

Phase 2

• Conditions: Health Condition 1: A90- Dengue fever [classical dengue]

• Registration Number: CTRI/2024/01/061272
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male or female, 18 - 60 years old (inclusive)

2.History or presence of fever (= 38°C) (could be based on medical record or measurement of body temperature) coinciding with a clinical suspicion of dengue infection at screening:

At least one of the following criteria indicating probable dengue infection:

•Nausea or vomiting

•Presence of rash, aches or pains including headache retro-orbital, muscle or joint pain.

3.Onset of fever = 48 hours prior to the administration of the first dose of study drug.

4.Positive NS1 rapid test or RT-PCR at screening.

5.Able to communicate well with the investigator, to understand and comply with the requirements of the study.

6.Written informed consent must be obtained before any assessment is performed.

Exclusion Criteria

Clinical signs and symptoms for severe dengue (listed in Section 8.3.2.3) according to Dengue Guideline (WHO 2009) at screening.

Participants with any of the following abnormalties 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 any anticoagulant drugs including, but not limited to, aspirin, warfarin, or clopidogrel at screening.

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.

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)

Current significant medical conditions or illness including cardiac arrhythmia, cardiomyopathy or other cardiac disease, asthma, or other respiratory disease, diabetes mellitus, renal or hepatic impairment, thyroid disease, Parkinson’s disease, epilepsy or history of unexplained blackouts, immunocompromised state including known HIV infection, or any other 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 at 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 five half-lives or 4 days whichever is longer after stopping of investigational drug.

Signs or symptoms, in the judgment of the investigator, of a clinically significant systemic viral, bacterial, parasitological, or fungal infection within 30 days prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified