NL-OMON48779已完成3 期
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection - Janssen Influenza A_3001
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 26
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Male or female, 13 to 85 years of age, inclusive. Note: Adolescent subjects
- •(13-17 years) will be enrolled in selected countries and study sites consistent
- •with local regulations.
- •* Tested positive for influenza A infection after the onset of symptoms using a
- •polymerase chain reaction (PCR)-based or other rapid molecular diagnostic
- •* Requires hospitalization to treat influenza infection and/or to treat
- •complications of influenza infection (eg, radiological signs of lower
- •respiratory tract disease, septic shock, central nervous system [CNS]
- •involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney
- •disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease,
- •exacerbation of underlying chronic pulmonary disease, including asthma, chronic
- •obstructive pulmonary disease [COPD], decompensation of previously controlled
- •diabetes mellitus), including subjects admitted to the intensive care unit
- •(ICU). Note: For the purpose of the protocol, subjects admitted under
- •*observation* status with an anticipated length of stay beyond 24 hours are
- •eligible for enrollment.
- •* Enrollment and initiation of study drug treatment *96 hours after onset of
- •influenza symptoms.
- •* Being on invasive mechanical ventilation or having an SpO2 <94% on
- •room air during screening. Subjects with known pre influenza SpO2 <94% must
- •have an SpO2 decline *3% from pre-influenza SpO2.
- •* Having a screening/baseline National Early Warning Score (NEWS2) of *4.
- •For a full list of inclusion criteria please refer to the protocol.
排除标准
- •* Received more than 3 doses of influenza antiviral medication (eg, oseltamivir
- •[OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first
- •study drug intake. Received intravenous (IV) peramivir more than one day prior
- •to screening.
- •* Unwilling to undergo regular nasal mid-turbinate (MT) swabs or has any
- •physical abnormality which limits the ability to collect regular nasal MT
- •* Unstable angina pectoris or myocardial infarction within 30 days prior to
- •screening (inclusive).
- •* Presence of clinically significant heart arrhythmias, uncontrolled, unstable
- •atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for
- •Torsade de Pointes syndrome.
- •* Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic
- •hepatitis C infection undergoing hepatitis C antiviral therapy.
- •* Severely immunocompromised in the opinion of the investigator (eg,
- •known cluster of differentiation 4+ [CD4+] count <200 cells/mm3, absolute
- •neutrophil count <750/mm3, first course of chemotherapy completed within 2
- •weeks prior to screening, history of stem cell transplant within 1 year prior
- •to screening, any history of a lung transplant).
- •For a full list of exclusion criteria please refer to the protocol.
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