Small scale preliminary clinical study on the intravenous administration of DP-b99 in the treatment of acute high-risk inflammation of the pancreas that occurs for the first time in the patient and is not due to obstruction of the main pancreatic duct

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 30

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:
- Typical upper abdominal pain.
- Elevation of serum amylase and/or lipase 3 times the upper limit of normal.
- 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 >= 3.
• Study treatment initiation is possible within 48 h of symptom onset.
• Ability to provide informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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 > 6 mm (above 80 years, > 8 mm) with gallbladder in situ.
• Severe chronic renal failure (Modification of Diet in Renal Disease formula <= 30mL/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 NYHA heart failure.
• Oxygen-dependent chronic obstructive pulmonary disease (COPD).
• Cirrhosis of the liver.
• Severe anemia (hemoglobin < 8 g/dL).
• Hematocrit < 35% or > 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 ALT >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 breast feeding or pregnancy.
• Female of childbearing potential (< 2 years postmenopausal or not surgically sterilized) who is not willing to use adequate and effective birth control measures (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner)) for the duration of the trial.
• 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 study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Effects of DP-b99 in subjects with high risk acute pancreatitis on systemic inflammation. <br>;Secondary Objective: Effects of DP-b99 in subjects with high risk acute pancreatitis on<br>• Safety<br>• Early clinical outcome (preliminary data);Primary end point(s): The primary study endpoint is to assess the effect of DP-b99 on systemic inflammation in acute pancreatitis as reflected by C-reactive protein (CRP) plasma levels.;Timepoint(s) of evaluation of this end point: Days 0, 1, 2, 3, 4, 5, 6

Secondary Outcome Measures

Name	Time	Method

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