ISRCTN16935761
Active, not recruiting
Phase 2
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 sites290 target enrollmentJune 8, 2018
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acute pancreatitis
- Sponsor
- niversity of Liverpool
- Enrollment
- 290
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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