A Pilot Study to Evaluate the Safety and Efficacy of IFN-alfacon1 (INFERGEN) in the Treatment of Hospitalized Patients Presenting With Influenza-like Illnesses Due to the Pandemic 2009 Swine Origin Influenza A Virus (S-OIV) H1N1 and Other Circulating Influenza Viruses
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Frequency of Clinically Important (moderate or severe) and serious adverse events
研究概览
简要总结
A Pilot Study to Evaluate the Safety and Efficacy of interferon-Alfacon1 (INFERGEN) in the treatment of patients hospitalized with Influenza-like illness caused by a novel swine origin Influenza virus and other circulating Influenza Viruses.
The use of Interferon-alfacon1 as a co-treatment along with the standard of care antiviral is hypothesized to be safe. Clinical improvement of patients is hypothesized to be quicker.
详细描述
The purpose of this study is to see if using a medication called INFERGEN, can help get rid of the virus and/or can help the immune response to prevent the illness from getting worse in the lungs. We hope that INFERGEN will either prevent patients from getting worse and requiring intensive care or will decrease the time for which they will need intensive care.
The Interferon-alpha (also called Interferon-alphacon1 or IFN-alphacon1 or INFERGEN) is an immune molecule, which has been shown to work against different viruses (anti-viral). Interferon is the standard of treatment for patients with chronic (infection that has been there for a long time) hepatitis C (a virus which affects the liver over many years) by giving it for 6-12 months. It has also been used for a shorter time of up to 14 days, in a small study for patients with respiratory disease caused by SARS and seemed to help these patients get better more rapidly. It also has been shown to stop different Influenza viruses from growing in test tubes and in lung tissue. It has also been shown to decrease the immune response to prevent it from over-reacting to viruses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Aged >=18 and < 70
- •Hospitalized
- •suspect, probable, confirmed influenza A
- •symptom onset <8 days
- •able to attend all scheduled visits
排除标准
- •known hypersensitivity to interferon preparation
- •pregnancy
- •chronic liver disease
- •moderate to severe congestive heart failure, grade III or IV left ventricular function
- •previous history of serious psychiatric illness
- •history of severe or active autoimmune disease
研究组 & 干预措施
Placebo
100 mM sodium Chloride and 25 mM sodium phosphate at pH 7.0 +/- 0.2
干预措施: Placebo (Drug)
Infergen
15mcg subcutaneous injection at fill volume of 0.5mL
干预措施: Interferon alfacon-1 (Drug)
结局指标
主要结局
Frequency of Clinically Important (moderate or severe) and serious adverse events
时间窗: Up to two-months post-treatment
occurrence, severity, time to onset, duration (number of days), seriousness, nature.
次要结局
- Virologic Clearance(Day 1,2-4,7,10,14, (21))
- Cytokines and PBMC(Day 1,2-4,7,10,14)
- Clinical Improvement(Duration of hospitalization)