CTRI/2024/01/061272招募中2 期
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 - NI
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
相似试验
进行中（未招募）
1 期
Study of efficacy and safety of LTP001 in pulmonary arterial hypertension participantsMedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary arterial hypertensionEUCTR2021-000670-28-DEovartis Pharma AG44
进行中（未招募）
1 期
Study of efficacy and safety of LTP001 in pulmonary arterial hypertension participantsMedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary arterial hypertensionEUCTR2021-000670-28-NLovartis Pharma AG44
进行中（未招募）
1 期
Study of efficacy and safety of LTP001 in pulmonary arterial hypertension participantsPulmonary arterial hypertensionEUCTR2021-000670-28-ESovartis Farmacéutica, S.A.44
招募中
2 期
A randomized, participant- and investigator-blinded, placebo-controlled study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension.NL-OMON51446ovartis4
进行中（未招募）
1 期
Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasisMedDRA version: 23.0Level: LLTClassification code 10083611Term: Non-cystic fibrosis bronchiectasisSystem Organ Class: 100000004855BronchiectasisEUCTR2019-002840-26-DEovartis Pharma AG72