NL-OMON44177已完成2 期
A PHASE 2 RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF MHAA4549A, A MONOCLONAL ANTIBODY, IN COMBINATION WITH OSELTAMIVIR VERSUS OSELTAMIVIR FOR TREATMENT OF SEVERE INFLUENZA A INFECTION - GNE Flu
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
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
- •Patients must meet the following criteria for study entry:
- •* Men or women * 18 years of age on day of signing informed consent or obtaining surrogate consent from an authorized representative
- •* Diagnosis of influenza A as determined by one or both of the following:
- •* A Sponsor-supplied rapid influenza test
- •* A local molecular test (PCR)
- •* One of the following markers of severity within 24 hours of hospital admission:
- •* Requirement for PPV, OR
- •* Requirement for O2 supplementation to maintain SpO2 >92%
- •* A negative urine or serum pregnancy test for women of childbearing potential
- •* Patients of reproductive potential must agree to use reliable means of contraception as described below as a minimum (adherence to more stringent local requirements may be required):
- •* For female patients: Use of two acceptable methods of contraception throughout the trial, including the active treatment phase AND for 120 days after the last dose of MHAA4549A. Acceptable methods of contraception include: intrauterine device, systemic hormonal contraception (oral or depot), vaginal ring, tubal ligation of the female partner, vasectomy of the male partner, use of latex condoms plus spermicide by the male partner, or cervical cap plus spermicide (where the spermicide could be foam, vaginal suppository, gel, cream, etc.). Male partners who have had a vasectomy should have the appropriate post-vasectomy documentation available of the absence of sperm in the ejaculate. The vasectomized male partner should be the sole partner for that subject.
- •* For male patients: Use condoms and refrain from sperm donation until 30 days after dosing.
- •* Non-reproductive potential is defined below (but could be superseded by local definitions, if they are more stringent):
- •Women who are postmenopausal (i.e., spontaneous amenorrhea for the past year confirmed by an follicle stimulating hormone [FSH] level greater than 40 mIU/mL unless the patient is receiving a hormonal therapy for their menopause)
- •Women who are surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy)
- •Men who are surgically sterile (castration)
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •* Pregnant or lactating, or intending to become pregnant during the study
- •* Women who are not postmenopausal (* 12 months of non-therapy-induced amenorrhea) or who are not surgically sterile must have a negative urine or serum pregnancy test result within 2 days prior to study treatment
- •* Hypersensitivity to monoclonal antibodies or to any constituents ( sodium succinate, sucrose, polysorbate 20) excipients of MHAA4549Astudy drug
- •* Hypersensitivity to the active substance or to any excipients of oseltamivir
- •* Investigational therapy within the 30 days prior to study treatment
- •* Received prior therapy with any anti-influenza monoclonal antibody therapy including MHAA4549A within 8 months prior to study treatment
- •* Current treatment (within 7 days of dosing) with amantadine or rimantidine
- •* Patients who have taken more than a total of 3 days (6 doses) of approved anti-influenza therapy (i.e., oral oseltamivir, inhaled zanamivir, lanimivir, peramivir) in the period from onset of symptoms and prior to enrollment
- •* Admission > 48 hours prior to study treatment
- •* Onset of influenza symptoms > 5 days prior to study treatment
- •* Positive influenza B or influenza A +B infection within 2 weeks prior to study treatment
- •* High probability of mortality in the next 48 hours as determined by the investigator
- •* Patient requiring home or baseline oxygenation therapy
- •* Patient with history of chronic lung disease resulting in baseline SpO2 <95%
- •* Patient on chronic dose of corticosteroids exceeding 10 mg/day of prednisone or equivalent steroid dose for a duration of greater than 14 days within 30 days of entry into study
- •* Patients with the following significant immune suppression:
- •* Bone marrow or solid organ transplant in the previous 12 months
- •* Cancer chemotherapy in the previous 12 month
- •* HIV infection with most recent CD4 < 200 cells/mL
- •* Other significant immune suppression as determined by the investigator in discussion with the Sponsor Medical Monitor or representative
- •* Patient on extracorporeal membrane oxygenation (ECMO) at time of randomization
- •* Any disease or condition that would, in the opinion of the site investigator or Sponsor, place the patient at an unacceptable risk of injury or render the patient unable to meet the requirements of the protocol
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