Post-market Safety Reassessment of Ulinastatin for Injection

• Conditions: Adverse Reaction to Drug
• Interventions: Drug: ulinastatin

• Registration Number: NCT02520570
• Lead Sponsor: Techpool Bio-Pharma Co., Ltd.

Brief 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.

Detailed 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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-13
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23
• Primary Completion: 2018-06
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Patients with ulinastatin treated

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU	ulinastatin	Patients using ulinastatin in ICU would be labelled as ICU group.
general department	ulinastatin	Patients using ulinastatin in department beyond ICU would be labelled as general department group.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	participants will be followed for the duration of using ulinastatin, an expected average of 7 days

Trial Locations

Locations (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China