Post-market Safety Reassessment of Ulinastatin for Injection

Adverse Reaction to Drug Clinical Trial

Official title:

Post-market Safety Reassessment of Ulinastatin for Injection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02520570
• Other study ID #: 002/20140709
• Status: Recruiting
• First received: July 30, 2015
• Last updated: April 19, 2018
• Start date: August 2014
• Est. completion date: August 2018

Study information

• Verified date: April 2018
• Source: Techpool Bio-Pharma Co., Ltd.
• Contact: mingjuan Hua, Master
• Phone: +86 020 38972288
• Email: huamj[@]techpool.com.cn
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: August 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with ulinastatin treated

Exclusion Criteria:

Related Conditions & MeSH terms

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

Intervention

Drug:
• ulinastatin
We wouldn't intervene the doctors how to treat with the patients or how to use the drug, we just observe the react of patients after treated with ulinastatin.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Techpool Bio-Pharma Co., Ltd.	Center for ADR Monitoring of Guangdong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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