Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
Phase 2
Terminated
- Conditions
- Bile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesPancreatitisPancreatic Diseases
- Registration Number
- NCT00040131
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 316
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
IL-10 anti-inflammatory mechanism post-ERCP pancreatitis cytokine suppression NF-kB pathway.
Efficacy IL-10 versus rectal indomethacin NSAIDs preventing post-ERCP pancreatitis meta-analysis.
Predictive biomarkers post-ERCP pancreatitis risk IL-10 treatment response inflammatory markers genetics.
Safety profile IL-10 Tenovil pancreatitis clinical trials adverse events NCT00040131 termination.
Immunomodulatory agents preventing post-ERCP pancreatitis somatostatin corticosteroids comparison IL-10 efficacy safety.