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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00040131

Enrollment

316

Registered

2002-06-21

Start date

2002-01-31

Completion date

2003-01-31

Last updated

2015-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Diseases, Biliary Tract Diseases, Gallbladder Diseases, Pancreatitis, Pancreatic Diseases

Brief 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.

Interventions

DRUGIL-10

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026