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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
Sponsor:
Information provided by (Responsible Party):
D-Pharm Ltd.

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.

Condition or disease Intervention/treatment Phase
Pancreatitis Drug: DP-b99 Drug: Placebo Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: DP-b99
Intravenous DP-b99, 1.0 mg/kg twice daily for 2 consecutive days
Drug: DP-b99
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)
Other Names:
  • Chemical name: 1,2-Bis(2-aminophenoxy)ethane- N,N,N'N'-tetraacetic acid, N,N'-di(octyloxyethyl ester), N,N'-disodium salt
  • CAS Number: 222315-66-4

Placebo Comparator: Placebo
Intravenous placebo (mannitol based, DP-b99 look-alike) twice daily for 2 consecutive days
Drug: Placebo
mannitol-based DP-b99 look-alike




Primary Outcome Measures :
  1. C-reactive protein serum concentration [ Time Frame: 6 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject.
  • Age 18 years or higher.
  • First in a lifetime episode of acute pancreatitis.
  • Diagnosis of acute pancreatitis based on 2 of the following 3 criteria: (1) typical upper abdominal pain; (2) elevation of serum amylase and/or lipase at least 3 times the upper limit of normal; (3) contrast-material enhanced CT scan or abdominal sonogram demonstrating changes of acute pancreatitis
  • History supporting alcoholic, hypertriglyceridemic or biliary etiology of the current pancreatitis episode (for biliary pancreatitis, a sonogram must exclude a stone obstruction at the time of study screening).
  • BISAP score of 3 or higher
  • Study treatment initiation is possible within 48 h of symptom onset
  • Ability to provide informed consent

Exclusion Criteria:

  • Drug-induced, viral, hereditary or post-ERCP pancreatitis.
  • Recurrent episode of pancreatitis.
  • CT evidence of pancreatic necrosis at study entry.
  • Imaging evidence of physical obstruction of the common bile duct at study entry; e.g. for abdominal sonogram, stone(s) in the common bile duct or common bile duct having diameter less than 6 mm (above 80 years, less than 8 mm) with gallbladder in situ.
  • Severe chronic renal failure (Modification of Diet in Renal Disease formula 30 mL/min or dependency on renal dialysis).
  • High likelihood for an invasive intra-biliary tract intervention (e.g. ERCP) in the coming week.
  • Class II or greater New York Heart Association heart failure.
  • Oxygen-dependent chronic obstructive pulmonary disease (COPD).
  • Cirrhosis of the liver.
  • Severe anemia (hemoglobin less than 8 g/dL).
  • Hematocrit below 35 % or above 45 % at study entry (fluids may be administered to correct the hematocrit before randomisation as long as study treatment starts within 48 hours of symptoms onset).
  • Serum alanine aminotransferase above 250 IU/L at study entry.
  • Clinical suspicion of ascending cholangitis at study entry.
  • Active gastrointestinal bleeding.
  • Current malignancy not in remission (other than basal cell carcinoma of skin).
  • Altered mental status.
  • Current breastfeeding or pregnancy.
  • Female of childbearing potential (less than 2 years postmenopausal or not surgically sterilized) who is not willing to use adequate and effective birth control measures
  • Known hypersensitivity to any component of the investigational product.
  • Dependent relationship with the investigator or the sponsor.
  • Participation in an investigational drug study during this clinical trial or within 30 days prior to start of this clinical trial

Information from the National Library of Medicine

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


Locations
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Czech Republic
The University Hospital Brno, Gastroenterology Clinic
Brno, Czech Republic, 62500
Sponsors and Collaborators
D-Pharm Ltd.
Investigators
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Study Director: Gilad Rosenberg, MD D-Pharm Ltd.

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Responsible Party: D-Pharm Ltd.
ClinicalTrials.gov Identifier: NCT02025049     History of Changes
Other Study ID Numbers: Ptcl-01501
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: December 2013
Keywords provided by D-Pharm Ltd.:
pancreatitis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Egtazic Acid
Antidotes
Protective Agents
Physiological Effects of Drugs
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action