NL-OMON48962已完成3 期
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BALOXAVIR MARBOXIL IN COMBINATION WITH A NEURAMINIDASE INHIBITOR VERSUS A NEURAMINIDASE INHIBITOR ALONE IN HOSPITALIZED PATIENTS WITH SEVERE INFLUENZA - CP40617
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Adult patients: signed Informed Consent Form
- •- Adolescent patients not able to legally consent: written informed
- •consent/assent for study
- •participation obtained from patient*s parents or legal guardian, with assent as
- •appropriate
- •by the patient, depending on the patient*s level of understanding
- •- Age * 12 years at the time of signing the Informed Consent Form/Assent Form
- •- Ability to comply with the study protocol, in the investigator*s judgment
- •- Patients who require hospitalization for severe influenza or acquire
- •influenza during
- •hospitalization, the severity of which requires an extension of hospitalization
- •- Diagnosis of influenza A and/or B by a positive Rapid Influenza Diagnostic
- •Test (RIDT) or
- •reverse transcriptase polymerase chain reaction (RT-PCR)
- •Positive results from local tests are acceptable if results are documented
- •previous 24 hours.
- •- The time interval between the onset of symptoms and randomization is within 5
- •The onset of symptoms is defined as the time when the patient experiences at
- •one new general symptom (headache, feverishness or chills, muscle or joint pain,
- •fatigue), respiratory symptom (cough, sore throat, nasal congestion), or fever.
- •- A score of * 4 based on the National Early Warning Score 2 (NEWS2)
- •- Patients will require objective criteria of seriousness defined by at least
- •one of the following
- •* Requires ventilation or supplemental oxygen to support respiration
- •* Has a complication related to influenza that requires hospitalization (e.g.,
- •CNS involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney
- •disease, asthma or chronic obstructive pulmonary disease [COPD], severe
- •dehydration,
- •myocarditis, pericarditis, ischemic heart disease)
- •- For women of childbearing potential: agreement to remain abstinent (refrain
- •heterosexual intercourse) women must remain abstinent or use contraceptive
- •methods with a failure rate of less than 1% per year
- •during the treatment period and for 28 days after the last dose of study
- •Hormonal contraceptive methods must be supplemented by a barrier method.
- •A woman is considered to be of childbearing potential if she is postmenarcheal,
- •reached a postmenopausal state (*12 continuous months of amenorrhea with no
- •identified cause other than menopause), and has not undergone surgical
- •sterilization
- •(removal of ovaries and/or uterus).
- •Examples of contraceptive methods with a failure rate of *1% per year include
- •tubal ligation, male sterilization, hormonal contraceptives that inhibit
- •hormone-releasing intrauterine devices, and copper intrauterine devices.
- •The reliability of sexual abstinence should be evaluated in relation to the
- •duration of the
- •clinical trial and the preferred and usual lifestyle of the patient. Periodic
- •(e.g., calendar, ovulation, symptothermal, or postovulation methods) and
- •are not acceptable methods of contraception
排除标准
- •- Patients who have received more than 48 hours of antiviral treatment for
- •influenza at the
- •time of screening
- •- Patients who have received baloxavir marboxil for the current influenza
- •- Known contraindications to the SOC NAI, unless an alternative NAI is
- •available for use in
- •- Known hypersensitivity to baloxavir marboxil or the drug product
- •- Patients hospitalized for social reasons (e.g., lack of carers at home)
- •- Patients expected to die or be discharged within 48 hours, according to the
- •investigator*s
- •- Patients weighing < 40 kg
- •- Patients with severe renal impairment (estimated glomerular filtration rate
- •*<30 mL/min/1.73 m2) or receiving continuous renal replacement therapy,
- •hemodialysis,
- •peritoneal dialysis
- •- Patients with any of the following laboratory abnormalities detected within
- •24 hours of
- •screening (according to local laboratory reference ranges if using local
- •laboratory data:
- •- ALT or AST level > 5 times the upper limit of normal (ULN)
- •- ALT or AST > 3 times the ULN and total bilirubin level > 2 times the ULN
- •* Pregnant or breastfeeding, or positive pregnancy test in a predose
- •examination, or
- •intending to become pregnant during the study or within 28 days after the last
- •dose of study
- •- Patients who have received treatment within 5 half-lives or 30 days
- •(whichever is longer) of
- •exposure to an investigational drug
- •- Any serious medical condition or abnormality in clinical laboratory tests
- •that, in the
- •investigator*s judgment, precludes the patient*s safe participation in and
- •completion of the
- •- Known hypersensitivity to baloxavir marboxil or the drug product excipients
研究者
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