Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)

• Status: Terminated
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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