Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
The purpose of this study is to determine if a single dose of IL-10 compared to placebo is
 safe and effective in reducing the incidence of post-ERCP acute pancreatitis for subjects
 with increased risk.
Inclusion criteria:

 Adults weighing up to 125 kg who are undergoing ERCP for any of the following:

 -  Evaluate recurrent abdominal pain;

 -  Evaluate unexplained recurrent pancreatitis;

 -  Evaluate prior post-ERCP pancreatitis;

 -  Treatment of pancreatic disorders;

 -  Treatment of Common Bile Duct Stones (without jaundice)

 Exclusion criteria:

 -  Active (acute) pancreatitis;

 -  Chronic pancreatitis (moderate and severe cases);

 -  ERCP to perform a second procedure on biliary tract;

 -  Patients who previously had pancreatic sphincterotomy;

 -  Known or suspected pancreatic cancer or cancer of Papilla of Vater;

 -  Known or suspected other malignancy;

 -  History of, or current clotting or bleeding problems;

 -  Moderate and severe Anemia;

 -  Low platelet counts