ISRCTN16935761进行中（未招募）2 期
Phase IIb, randomised, double-blind, placebo-controlled, multi-centre trial of infliximab with transcriptomic biomarker and mechanism evaluation in patients with acute pancreatitis
niversity of Liverpool0 个研究点目标入组 290 人开始时间: 2018年6月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 290
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
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 14/08/2018:
- •1. Adult patients attending A&E at or admitted to recruiting hospitals via a general practitioner with a new diagnosis of AP established by two of:
- •1.1. Typical continuous upper abdominal pain;
- •1.2. Amylase and/or lipase three or more times the upper limit of normal;
- •1.3. Characteristic findings on abdominal imaging (if undertaken urgently by CT or magnetic resonance imaging, MRI);
- •2. Patients in whom trial treatment can be started within 12 hours of recorded admission and allowing 120 min for pharmacy to prepare trial medication
- •3. Patients from whom appropriate consent is obtained (consent to be given by the patient or their legal representative).
- •Previous participant inclusion criteria:
- •1. Adult patients attending A&E at recruiting centres from whom appropriate consent is obtained (consent to be given by the patient or their legal representative)
- •2. Patients in whom trial treatment can be started within 12 hours of admission (allowing 120 min for Pharmacy to prepare trial medication)
- •3. A new diagnosis of AP (all severity levels) as established by two of:
- •3.1. Typical continuous upper abdominal pain
- •3.2. Amylase and/or lipase three or more times the upper limit of normal
- •3.3. Characteristic findings on abdominal imaging (if undertaken urgently)
- •NB Please note all severity levels of AP are to be included in the trial
排除标准
- •1. Age < 18 or > 85
- •2. Body weight > 200 kg
- •3. Onset of abdominal pain more than 24 hours before admission to hospital
- •4. Known previous acute pancreatitis or chronic pancreatitis
- •5. Known multiple sclerosis, systemic vasculitis, Guillain-Barré syndrome or other demyelinating disorder
- •6. Known epilepsy
- •7. Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV)
- •8. On home oxygen or home mechanical ventilation
- •9. Known advanced liver disease, on waiting list for liver transplantation or considered unsuitable for transplantation
- •10. Known cancer for which chemotherapy and/or radiotherapy is ongoing or was completed within less than 6 months from admission
- •11. Known haematological malignancy
- •12. Known cancer that is end-stage with ongoing palliative care or for which palliative care is appropriate
- •13. Known established infection prior to the onset of acute pancreatitis
- •14. Known history of (including that identified on chest x-ray) or household contact with individuals who have tuberculosis or opportunistic infection
- •15. Known history of infective hepatitis
- •16. Known immunosuppressive or biologic therapy within one month of admission
- •17. Known live vaccines or therapeutic infectious agents within one month of admission
- •18. Known hypersensitivity to infliximab or to inactive components of REMICADE® or to any murine proteins
- •19. Known pregnancy or lactation at the time of admission
- •20. Women of childbearing potential who do not agree to use adequate contraception up to Day 90
- •21. Known to be currently participating in a trial testing any investigational medicinal product or participation in a clinical study involving a medicinal product in the last three months
研究者
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