A Randomised, Parallel Group 2:1 Comparison of the Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) and Placebo in the Prevention of Multi-Organ Failure on Patients Surviving Open Surgery for a Ruptured Abdominal Aortic Aneurysm
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 9
- 主要终点
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality
研究概览
简要总结
A study to assess effectiveness and safety of a drug FP-1201-lyo (Recombinant Human Interferon Beta-1a) in the Prevention of Multi-Organ Failure on patients after Open Surgery for a Ruptured Abdominal Aortic Aneurysm
详细描述
This trial is multicentre, randomised, double-blinded, Phase II, parallel group comparison study of the efficacy and safety of FP-1201-lyo compared to placebo in patients surviving emergency open surgery for an infra-renal ruptured abdominal aortic aneurysm. Investigational medicinal product will be administered as post-surgical preventive treatment either 10µg FP-1201-lyo or placebo. Treatment will be administered daily every 24 hrs for 6 days. The first dose will be given after successful surgery at the point when the patient arrives to the Intensive Care Unit (ICU).
Both treatment groups will receive standard supportive care.
Aim is randomise and initiate treatment of 152 patients. For the final analysis, a minimum of 129 evaluable patients will be required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for inclusion into this study, each patient must fulfil the following inclusion criteria during screening and prior to the first dose of study medication being administered on D0 (criteria 1 or 2 and all 3, 4 and 5):
- •Patients (male or female) presenting with a ruptured abdominal aortic aneurysm (RAAA) diagnosed by ultrasound or CT-scan in the emergency room
- •all forms of infrarenal RAAAs with or without coexisting iliac aneurysms are included or
- •Patients (male or female) presenting with symptoms of RAAA known to have an infrarenal AAA and proceeding straight to open repair without radiological assessment and confirmed rupture (=retroperitoneal haematoma) in operation
- •Aneurysma repair must be infra-renal, i.e. the proximal anastomosis must be below the renal arteries and the renal arteries have to stay intact. Temporary above the renal clamping can be used for a maximum of 30 minutes (total clamping time)
- •Patients providing informed consent
- •Age of 18 years or higher
排除标准
- •To be eligible for inclusion into this study, each patient must not meet any of the following exclusion criteria during screening or prior to the first dose of study medication being administered:
- •Moribund patient not eligible for treatment in ICU or expected to survive surgery
- •Markedly short life expectancy, e.g. advanced malignant disease
- •Current participation in another experimental treatment protocol
- •Significant congestive heart failure, defined as New York Heart Association (NYHA) class IV
- •Current treatment with Interferon (IFN) alpha or IFN beta
- •Dialysis therapy for chronic renal failure
- •Irreversible shock from haemorrhage
- •Unconsciousness or inability to give consent
- •Ruptured Endovascular Aortic Repair (rEVAR) first (prior attempt for endovascular aortic repair for the current rupture)
- •Diagnosed cirrhosis
- •Pregnancy and women with child bearing potential without negative pregnancy test
- •Rupture not confirmed by CT or intra-operatively (impending ruptures are excluded)
- •RAAA requiring repair of the renal arteries or the proximal aorta
- •thoracoabdominal aneurysms requiring immediate repair
- •damaged renal arteries during emergency clamping requiring repair
- •temporary clamping above the renal arteries (max 30 min total clamping time above the renal arteries) does not lead to exclusion
- •ligation of the left renal vein does not lead to exclusion
研究组 & 干预措施
FP-1201-lyo 10 µg
FP-12-lyo 10 µg (Interferon Beta-1a) will be administered once daily as an intravenous bolus injection for 6 days.
Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.
干预措施: Interferon Beta-1A (Drug)
FP-1201-lyo Placebo
FP-1201-lyo Placebo will be administered once daily as an intravenous bolus injection for 6 days.
Investigational placebo is lyophilisate for solution for injection which will be reconstituted in water for injection
干预措施: Placebo (Drug)
结局指标
主要结局
The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality
时间窗: Day 30
Number of fatalities
次要结局
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Ventilator Free Days (VFDs)(Day 30)
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Organ Failure Free Days by Means of the Sequential Organ Failure Assessment (SOFA) Score(Day 30)
- Safety Parameters of Clinically Significant Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events, Vital Signs and Clinical Laboratory Parameters(Day 0 to Day 30)
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning Number of Days Receiving Hemodialysis(Day 30 and Day 90)
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning Neutralizing Antibodies Against IFN Beta-1a (NAbs) in Whole Blood Samples(Day 30)
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning All Cause Mortality(Day 90)
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning Prevalence of Abdominal Compartment Syndrome by Intra-abdominal Pressure (IAP)(Days 1 - 6, D9 and D13 during Intensive Care Unit (ICU) stay)
- The Efficacy of FP-1201-lyo Compared to Placebo Concerning Disability by Modified Ranking Scale (mRS).(Day 90)
- Pharmacoeconomic Information of Length of ICU Stay, Length of Hospital Stay, Length of Stay at Another Health Care Facility, Length of Hemodialysis Needed, Ventilation Free Days(Day 30 or Day 90)