EUCTR2017-002156-84-AT进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •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 assay.
- •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 during screening.
- •Having a screening/baseline National Early Warning Score (NEWS) of =4.
- •Treatment Extension Criteria - Subjects will be given the option for treatment extension in case all of the following conditions are met:
- •The subject completed the 5-day treatment period.
- •The subject is still hospitalized.
- •The subject is on invasive mechanical ventilation or has an ongoing respiratory deficiency as evidenced by having an SpO2 <94% on room air, or in case of known pre-influenza SpO2 <94% (eg, due to COPD), the current blood oxygen saturation on room air is lower than pre-influenza infection levels by at least 3%.
- •The subject is expected to derive clinical benefit from extending the treatment period, in the opinion of the investigator.
- •The investigator agrees to extend treatment with the same SOC. If the SOC contained no influenza antiviral during the first treatment period, no influenza antiviral can be started in the treatment extension as part of the SOC.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 270
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 specimens.
- •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).
研究者
相似试验
进行中（未招募）
1 期
Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)Crohn's diseaseEUCTR2017-000575-88-LTShire Human Genetic Therapies, Inc.1,032
进行中（未招募）
1 期
Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo.Crohn's diseaseEUCTR2017-000617-23-HUShire Human Genetic Therapies, Inc.983
进行中（未招募）
1 期
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)EUCTR2017-000572-28-HUShire Human Genetic Therapies, Inc.279
进行中（未招募）
1 期
Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306).EUCTR2017-000576-29-HUShire Human Genetic Therapies, Inc.1,032
进行中（未招募）
1 期
A study of AMG 386 or placebo in combination with paclitaxel and carboplatin to treat ovarian cancerEUCTR2011-001112-53-DEAmgen Inc.1,000