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Post-market Safety Reassessment of Ulinastatin for Injection

NCT02520570 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2018-04-23

No results posted yet for this study

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.

Conditions

  • Adverse Reaction to Drug

Interventions

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.

Sponsors & Collaborators

  • Center for ADR Monitoring of Guangdong

    collaborator UNKNOWN

  • Techpool Bio-Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jin Li, doctor · Center for Adverse Drug Reaction Monitoring of Guangdong

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-06-30
Completion
2018-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520570 on ClinicalTrials.gov