Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Condition or disease
Bile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesPancreatitisPancreatic Diseases
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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;