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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Gallbladder Diseases; Pancreatic Diseases; Bile Duct Diseases; Pancreatitis; Biliary Tract Diseases

Treatments: Drug: IL-10

Study type: Interventional

Funder types: Industry

Identifiers

NCT00040131

P02580

Details and patient eligibility

About

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.

Enrollment: 316 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind