EUCTR2016-002688-32-ES进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared with Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients with Influenza at High Risk of Influenza Complications
Shionogi Ltd.0 个研究点目标入组 2,157 人开始时间: 2017年7月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,157
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
- •Patients who fulfill all of the following criteria will be included in the study:
- •1. Patients or their legal guardians who provide written informed consent to participate in the study on a voluntary basis. For adolescent patients, informed consent/assent of voluntary participation should be obtained in accordance with local requirements.
- •2. Male or female patients = 12 years at the time of signing the informed consent/assent form.
- •3. Patients with a diagnosis of influenza confirmed by all of the following:
- •a. Fever = 38ºC (axillary) during the predose examinations or > 4 hours after dosing of antipyretics if they were taken
- •b. At least 1 each of the following general and respiratory symptoms associated with influenza (excluding those that are chronic and existed in teh 30 days prior to the influenza episode) is present with a severity of moderate or greater:
- •i. General symptoms (headache, feverishness or chills, muscle or joint pain, or fatigue)
- •ii. Respiratory symptoms (cough, sore throat, or nasal congestion)
- •4. The time interval between the onset of symptoms and the predose examinations (Screening) is 48 hours or less. The onset of symptoms is defined as either:
- •a. Time of the first increase in body temperature (an increase of at least 1ºC from normal body temperature)
- •b. Time when the patient experiences at least 1 new general or respiratory symptom
- •5. If a women of childbearing potential, agrees to use a highly effective method of contraception for 3 months after the first dose of S-033188 or oseltamivir.
- •6. Patients will be considered at high risk of influenza complications due to the presence of at least 1 of the following inclusion criteria:
- •a. Asthma or chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
- •b. Endocrine disorders (including diabetes mellitus)
- •c. Residents of long-term care facilities (eg, nursing homes)
- •d. Compromised immune system (including patients receiving corticosteroids not exceeding 20 mg of prednisolone or equivalent, and patients being treated for human immunodeficiency virus (HIV) infection with a CD4 count > 350 cells/mm3 within the last 6 months)
- •e. Neurological and neurodevelopmental disorders (including disorders of the brain, spinal cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy [seizure disorders], stroke, muscular dystrophy, or spinal cord injury)
- •f. Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart-related symptoms
- •g. Adults aged = 65 years
- •h. American Indians and Alaskan Natives
- •i. Blood disorders (such as sickle cell disease)
- •j. Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
- •k. Morbid obesity (body mass index = 40)
- •l. Women who are within 2 weeks postpartum and are not breastfeeding
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 431
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 863
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 863
排除标准
- •Patients who meet any of the following criteria will be excluded from the study:
- •1. Patients with severe influenza virus infection requiring inpatient treatment.
- •2. Patients with known allergy to oseltamivir (Tamiflu®).
- •3. Patients unable to swallow tablets or capsules.
- •4. Patients who have previously received S-033188.
- •5. Patients weighing < 40 kg.
- •6. Patients who have been exposed to an investigational drug within 30 days prior to the predose examinations.
- •7. Women who are pregnant, breastfeeding, or have a positive pregnancy test at the predose examinations. The following female patients who have documentation of either a or b below do not need to undergo a pregnancy test at the predose examinations:
- •a. Postmenopausal women (defined as cessation of regular menstrual periods for 2 years or more and confirmed by a follicle-stimulating hormone test)
- •b. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation
- •8. Patients with concurrent infections at the predose examinations requiring systemic antimicrobial therapy.
- •9. Patients with liver disease associated with hepatic impairment.
- •10. Patients with cancer within the last 5 years (unless nonmelanoma skin cancer).
- •11. Patients with untreated HIV infection or treated HIV infection with and unknown CD4 count or CD4 count below 350 cells/mm3 in the last 6 months.
- •12. Patients with immunosuppression following organ or bone marrow transplants.
- •13. Patients exceeding 20 mg of prednisolone or equivalent dose of chronic systemic corticosteroids.
- •14. Patients who have received peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to the predose examinations.
- •15. Patients who have received an investigational monoclonal antibody for a viral disease in the last year.
- •16. Patients with current creatinine clearance = 60 mL/min (= 30 mL/min in Japan)
- •17. Patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose intolerance.
- •18. Pediatric patients in countries where national legislation prohibits the conduct of studies with a placebo arm in pediatrics.
- •19. Patients who, in the opinion of the investigator, whould be unlikely to comply with required study visits, self assessments, and interventions.
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