Post-market Safety Reassessment of Ulinastatin for Injection

NCT02520570 | Unknown DMC

• 1 other identifier: 002/20140709
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc )
2. 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. 3.Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.

Conditions

Adverse Reaction to Drug

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

general department

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

Drug: ulinastatin

ICU

Patients using ulinastatin in ICU would be labelled as ICU group.

Drug: ulinastatin

Interventions

ulinastatin DRUG

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.

Also known as: UTI, urinary trypsin inhibitor, bikunin

ICU; general department

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with ulinastatin treated

You may qualify if:

• Patients with ulinastatin treated

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Center for ADR Monitoring of Guangdong: collaborator
• Techpool Bio-Pharma Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510115, China

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

urinastatin

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Jin Li, doctor

  Center for Adverse Drug Reaction Monitoring of Guangdong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mingjuan Hua, Master

CONTACT

+86 020 38972288; huamj@techpool.com.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

CN (1)