DP-b99 in the Treatment of Acute High-risk Pancreatitis

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: D-Pharm Ltd.

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