EUCTR2015-003002-17-BE进行中（未招募）1 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult and Elderly Hospitalized Patients With Influenza A Infection
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Participants requires hospitalization to treat influenza infection and/or to treat complications of influenza infection
- •- Participants tested positive for influenza A infection within 1 day of signing of the informed consent form (ICF)/assent form using a polymerase chain reaction (PCR)-based rapid molecular diagnostic assay
- •- Participants must be capable of swallowing study medication tablets and capsules
- •- Each participant (or their legally acceptable representative) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
- •- Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •- Participants received more than 3 doses of the influenza antiviral medication oseltamivir, zanamivir, or peramivir since the start of the influenza symptoms, or ribavirin within 6 months prior to Screening
- •- Participant is unwilling to undergo regular nasal Mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal specimens
- •- Participants is immunocompromised, whether due to underlying medical condition (example, malignancy) or medical therapy (example, medications, chemotherapy, radiation, post-transplant)
- •- Participant is undergoing peritoneal dialysis, hemodialysis, or hemofiltration
- •- Participant has an estimated glomerular filtration rate (eGFR) less than or equal to (<=)30 milliliter (mL)/minute (min)/1.73 meter^2 (m^2) according to the Modification of Diet in Renal Disease (MDRD) equation, assessed at Screening or based on the most recent clinically relevant creatinine value if available
- •- Partcipant has a known diagnosis of acute viral hepatitis
研究者
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