Clinical Trial: DP-b99 in the Treatment of Acute High-risk Pancreatitis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Pilot Trial of Intravenous DP-b99 in the Treatment of First-ever Episode of Non-obstructive Acute High-risk Pancreatitis
Brief Summary: Inflammation of the pancreas often leads to severe damage not only to the pancreas but also to other organs in the abdomen as well as to complications in organs further away like the lung and the kidney. This trial will examine if DP-b99, given to patients with non-severe inflammation of the pancreas, can mitigate the development of processes that can lead to serious complications of this disease.
Detailed Summary:
The study will be a randomised, double blind, placebo-controlled, multi-centre, multi-national, parallel-arm study comparing a placebo group to a DP-b99 group treated intravenously with 1.0 mg/kg twice daily for 2 consecutive days.
The study will enrol 30 patients at high risk of developing severe pancreatitis, as assessed by the Bedside Index for Severity in Acute Pancreatitis (BISAP) score of 3 or more at study entry.
The primary study endpoint is the effect of DP-b99 on systemic inflammation in acute pancreatitis as reflected by C-reactive protein (CRP) plasma levels. The secondary endpoints are the safety of DP-b99 in this population of patients (through routine safety laboratory tests, physical examination and vital signs monitoring, ECG and adverse event reporting), DP-b99's effects on other plasma inflammatory markers (interleukin-6, matrix metalloproteinase 9, tumor necrosis factor alpha) as well as its effects on the clinical course of pancreatitis (based on changes in the Systemic Inflammatory Response Syndrome (SIRS) and Acute Physiology And Chronic Health Evaluation II (APACHE II) scores, and on contrast material-enhanced abdominal Computerised Tomography (CT), versus placebo.
Clinical trial material administration will begin within 48 hours of acute pancreatitis symptoms onset. Subjects will be randomised at a ratio of 1:1 to receive either DP b99 or placebo. The serum levels of DP-b99 at the end of each 2-hour infusion will also be monitored.
The study duration per individual subject will be 14 days, consisting of a screening evaluation followed by a 48-hour double blind treatment period, which will be part of an in-hospital observation period of at least 6 days, and a follow-up final visit on Day 14.
Sponsor: D-Pharm Ltd.
Current Primary Outcome: C-reactive protein serum concentration [ Time Frame: 6 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: D-Pharm Ltd.
Dates:
Date Received: December 25, 2013
Date Started: December 2013
Date Completion:
Last Updated: June 22, 2015
Last Verified: December 2013
