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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2003-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bile Duct Diseases Biliary Tract Diseases Gallbladder Diseases Pancreatitis Pancreatic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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IL-10

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No