DP-b99 in the Treatment of Acute High-risk Pancreatitis
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|ClinicalTrials.gov Identifier: NCT02025049|
Recruitment Status : Terminated (Slow recruitment)
First Posted : December 31, 2013
Last Update Posted : June 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis||Drug: DP-b99 Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Pilot Trial of Intravenous DP-b99 in the Treatment of First-ever Episode of Non-obstructive Acute High-risk Pancreatitis|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Intravenous DP-b99, 1.0 mg/kg twice daily for 2 consecutive days
DP-b99 is a lipophilic analog of the divalent metal ion chelator O,O'-Bis(2-aminophenyl) ethyleneglycol-N,N,N',N'-tetraacetic acid (BAPTA)
Placebo Comparator: Placebo
Intravenous placebo (mannitol based, DP-b99 look-alike) twice daily for 2 consecutive days
mannitol-based DP-b99 look-alike
- C-reactive protein serum concentration [ Time Frame: 6 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025049
|The University Hospital Brno, Gastroenterology Clinic|
|Brno, Czech Republic, 62500|
|Study Director:||Gilad Rosenberg, MD||D-Pharm Ltd.|