Post-market Safety Reassessment of Ulinastatin for Injection

Status Recruiting

Clinical Trial Summary

1. Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc )

2. Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect the main clinical manifestations, treatment, outcome, influence factors; provide evidence for improving the recommended medication plan of ulinastatin.

3. Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.

Clinical Trial Description

In order to find out the application of ulinastatin in real practice clinic , identify the high risk group for adverse event/adverse drug reaction and calculate the adverse event/adverse drug reaction incidence rate, a large sample size clinical trial has been designed. This trial is an observational study. The investigators would screen several hospitals from different provinces and prospectively collect the main clinical manifestations,treatment, outcome, influence factors about patients using ulinastatin either in general clinical departments or in ICU. This study would be expected to provide evidence for appropriate medication to administration department of health authority. ;

Study Design

Related Conditions & MeSH terms

Adverse Reaction to Drug
Drug-Related Side Effects and Adverse Reactions

Clinical Trial Details

NCT number	NCT02520570
Study type	Observational
Source	Techpool Bio-Pharma Co., Ltd.
Contact	mingjuan Hua, Master
Phone	+86 020 38972288
Email	huamj@techpool.com.cn
Status	Recruiting
Phase
Start date	August 2014
Completion date	August 2018

View Details

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